July 20, 2017
Breast-feeding may reduce the mother’s MS risk….
July 19, 2017
The loss of smell can impact many with MS….
July 17, 2017
Important updates from two recent MS conventions….
July 13, 2017
The way in which patients with multiple sclerosis answer questionnaires could help to predict their survival rate…
July 6, 2017
A readily available, over-the-counter antioxidant may help to slow the progression of MS….
May 30, 2017
The 2017 edition of MSAA’s MS Research Update provides a comprehensive overview of the study results on many experimental treatments currently under investigation…
May 18, 2017
It is commonly thought that in MS, the loss of axons (nerve fibres) contributes to the chronic disability, however…..
May 10, 2017
Alemtuzumab improves long-term clinical and radiological outcomes in black patients….
April 19, 2017
Ask the Doctor, Evaluating the Hereditary Risk of MS
April 17, 2017
Stories to Inspire, Family Comes First….
April 15, 2017
MRI Access Fund Now Fully Restored….
March 30, 2017
New gene interaction associated with increased MS risk….
March 29, 2017
Researchers say that they may have found a way to restore myelin formation….
March 28, 2017
The humanized monoclonal antibody ocrelizumab became the first drug to receive approval from the Food and Drug Administration for the treatment of primary progressive multiple sclerosis….
March 2, 2017
Weekly videos for the month of March for MS Awareness Month….
March 1, 2017
New technology improves cognition….
February 23, 2017
Stem cell transplantation may halt disease progression….
February 13, 2017
Individuals with Medicare and private health insurance who cannot meet their co-insurance balance are now eligible to apply for funding assistance for a cranial magnetic resonance imaging (MRI) exam….
February 9, 2017
Diagnosing MS can sometimes be difficult because there isn’t one single definitive test for the disease. Therefore, if a doctor suspects a person has MS, they may be referred to a neurologist who specializes in caring for people with MS….
January 26, 2017
Different types of MS and symptoms to look for…
January 25, 2017
Severe side effects have been found…..
January 24, 2017
The tests used to diagnosis MS….
January 11, 2017
Brain may continue to grow, or at least one part may…
December 14, 2016
Before scheduling an operation, consider these important questions…
December 14, 2016
Going on Record: Patients have a right to their medical records but often don’t know how to access them…
December 6, 2016
Stem Cell Reality: Desperate patients are vulnerable to the promise of stem cell therapy—most of it unproven…
November 25, 2016
Sexual Healing: A neurologic diagnosis doesn’t mean the end of intimacy….
October 12, 2016
Information about stem cell treatment…
September 9, 2016
The cost of multiple sclerosis (MS) care is rising due to escalating prices of disease-modifying therapies (DMTs) over the last several years. Insurers have responded by passing some of the cost to the patient in the form of denying costly therapies or limiting payment, which may have a negative effect on MS care.
August 31, 2016
A Phase III study with siponimod, an experimental oral treatment for MS, is showing positive results for individuals with secondary-progressive multiple sclerosis.
August 22, 2016
Fatigue is one of the most disabling side effects in people with multiple sclerosis. Learn more by clicking the link below…
July 21, 2016
Two vital conferences providing the latest information and research on multiple sclerosis (MS) take place in the spring of each year….
July 5, 2016
The MS MRI fund has returned!
MSAA has temporarily reopened our longstanding and highly-requested MRI Access Fund Program. Through recent support from Teva Neuroscience, MSAA has been able to lift the program’s six-month suspension and resume processing MRI requests for MS diagnostic and follow-up exams until funds are exhausted.
MSAA will only accept the updated 2016 MRI Access Fund application, which requires the submission of documented income and insurance information. As with before, applications will be processed on a first-come, first-serve basis; no emergency situations apply; and no reimbursements provided for previous MRIs.
MSAA is extremely pleased to resume this critically important service to the MS community while we continue to work on securing additional grants and restoring the MRI Access Fund to its full level of service. If you have any questions, please call (800) 532-7667, ext. 120.
July 4, 2016
Genentech today announced that its Biologics License Application for ocrelizumab, marketed as Ocrevus™, has been accepted for review by the US FDA.
July 1, 2016
A new study provides further confirmation of a link between obesity and MS.
June 15, 2016
Spasticity, which is an involuntary tightness or stiffness of the muscles, is one of the most common symptoms of multiple sclerosis….
June 2, 2016
This monoclonal antibody is self-administered subcutaneously (under-the-skin) once per month and has been shown to reduce the number of relapses….
May 17, 2016
Epidemiological studies indicate that vitamin D might be particularly important for people with MS…
May 16, 2016
Patients with multiple sclerosis (MS) who are treated with mitoxantrone may have a greater risk of colon cancer and acute myeloid leukemia…
May 12, 2016
Using pre-clinical models for multiple sclerosis (MS) and samples from MS patients, the team found evidence that changes in diet and gut flora may influence astrocytes in the brain…
May 9, 2016
The editorial staff of Neurology Reviews has collected its on-site reporting from the 68th Annual Meeting of the American Academy of Neurology and here’s the online digital edition.
April 15, 2016
A common antihistamine available over the counter has shown evidence of remyelination in patients with MS in a double-blind, placebo-controlled trial…
April 14, 2016
April 13, 2016
A group of T2 weighted hyperintensities that disseminate in what is called a “punctate pattern” (PP) may directly precede the appearance of progressive multifocal leukoencephalopathy (PML) lesions…
April 12, 2016
Certain MS treatment may be linked to shingles…
April 11, 2016
Smoking may be linked to abnormalities in the brain…
March 31, 2016
See how stem cells are used in MS treatment…
March 30, 2016
Social Security Inspector General Patrick P. O’Carroll is warning citizens to be aware of phone calls from unknown people who claim to have information about a citizen’s application for disability benefits…
March 20, 2016
To view the latest in MS news from Neurology Review visit:
March 15, 2016
The latest innovations and late-phase studies in the drug pipeline for Multiple Sclerosis….
March 14, 2016
The antidiabetic agents metformin and pioglitazone appear to have beneficial anti-inflammatory effects in patients with comorbid multiple sclerosis (MS) and metabolic syndrome…
February 17, 2016
Andrew Liebig of Wasilla has an amazing all-terrian motorized chair that may be available to other Alaskans with MS. See how a special program may help you or someone you know…
February 16, 2016
Breakthrough Therapy Designation” for ocrelizumab, an experimental medication presently under investigation for the treatment of primary-progressive multiple sclerosis
January 6, 2016
T-cell biomarker not viable for detecting PML…
December 27, 2015
Visit the MS Foundation’s newsletter…
December 16, 2015
Death of nerve cells that make myelin may trigger an autoimmune response…
December 15, 2015
Study of neurological disorders of Gulf War vets…
December 2, 2015
Estrogen has been found to help prevent relapses…
December 1, 2015
Growing nerve cells may lead to transplants…
November 24, 2015
Highlights from the Joint ACTRIMS-ECTRIMS Meeting…
November 16, 2015
The benefits of exercise for those with MS…
September 16, 2015
Smoking after diagnosis may worsen disease faster…
September 15, 2015
MS changes with less daylight…
September 9, 2015
The benefits from breastfeeding…
September 8, 2015
How animal cells may help…
September 3, 2015
Letter from a mother with MS to a son who doesn’t understand…
September 3, 2015
Brother struggle showed bravery…
September 2, 2015
What may lead to increasing disability for some MS patients…
September 1, 2015
Vitamin D levels linked to MS risk…
August 24, 2015
Stem cell update for MS…
August 23, 2015
Wellness moves to the forefront at latest meeting…
August 15, 2015
New iOS and Android app from MSAA to help manage your MS and directly link to your physician.
July 23, 2015
Salt may worsen MS symptoms…
June 9, 2015
Highlights from the American Academy of Neurology’s 67th Annual Meeting that took place in Washington, DC from April 18th-25th….
May 27, 2015
“MS and the Gut”
May 20, 2015
Genetic variant predicts likelihood of patient’s response to treatment….
Researchers have found what may be a cause of the disease….
May 18, 2015
Study links processed foods to autoimmune diseases….
Major progressive MS trial….
May 6, 2015
Scientists find a possible new treatment for autoimmune disorders….
April 29, 2015
Once daily MS pill (Gilenya) reaches new treatment goal….
Plegridy three-year data supports long term safeety and efficacy in MS patients….
Effect of Lemtrada on slowing brain atrophy and MRI lesion activity….
Drug prices to treat MS soar….
April 17, 2015
FDA approves Glatopa™ (glatiramer acetate injection) for the treatment of individuals with relapsing forms of multiple sclerosis….
April 13, 2015
Menarche, Menstruation, Menopause, and MS is one video. Second is Pregnancy and the MS Patient: Pre-Pregnancy through Post-Partum
April 12, 2015
A comprehensive tutorial reference detailing our current understanding of Multiple Sclerosis
April 10, 2015
Are stem cell transplants superior to Mitoxantrone for severe MS?
No evidence of disease activity may have predictive value….
April 1, 2015
Major new study in Great Britain on how people with MS can overcome problems with attention and memory….
March 12, 2015
Copaxone lipoatrophy more common than reported…..
Can exercise help?…..
March 11, 2015
The invisible difficulties…..
Article on genetic risk factors…..
Approved drug is a myelin-maker…..
March 10, 2015
February 19, 2015
MSAA offers an extensive library of on-demand video programming, webcasts, professionally monitored chat rooms, and additional interactive communication features that bring knowledge and empowerment right into the privacy and comfort of a person’s home.
February 18, 2015Stem Cell transplants may be more effective than drugs for people with severe cases of MS, according to a new study…
February 12, 2015
The full pathological progress of multiple sclerosis has been documented…
February 4, 2015
IMPORTANT news about MSAA merging MRI Programs into the MRI Access Fund
January 15, 2015
Collaboration aims to reduce neurodegeneration
January 7, 2015
Report on remission in MS patients 3 years after stem cell transplant……
December 17. 2014
Researchers will track the lives of people with multiple sclerosis (MS) in unprecedented detail in a project to improve the evaluation of treatments.
December 10, 2014
UC Riverside-led mouse study shows the ligand indazole chloride improves motor function, imparting therapeutic benefits even when treatment is initiated at the peak of disease.
In a new study published in the journal Frontiers in Neurology, a team of researchers led by the University of Surrey, have identified a rogue protein in multiple sclerosis, which attacks the body’s central nervous system. Researchers believe this finding could pave the way for better understanding of multiple sclerosis and new treatments against neurodegenerative diseases.
November 16, 2014
Lemtrada™ Receives FDA Approval for Relapsing Forms of MS – Please see MSAA’s online news article for more information!
If links are disabled in this email, please copy and paste the following address into your web browser to view the full article:
November 5, 2014
New tool helps make sense of previous genetic data on multiple sclerosis:
October 30, 2014
August 19, 2014
Plegridy™ Approved for
Relapsing Forms of MS
On August 15, 2014, Biogen Idec announced that the United States Food and Drug Administration (FDA) approved Plegridy™ (
As with all of the approved DMTs for MS, Plegridy is not a cure, but does slow MS disease activity. It reduces the annual relapse rate (ARR) as well as the number and size of brain lesions (areas of inflammation) as seen on magnetic resonance imaging (MRI) scans. Additionally, Plegridy reduced the risk of 12-week confirmed disability progression, as measured by the Expanded Disability Status Scale (EDSS).
If links are disabled in this email – to read the full article, copy and paste the following into your web browser:
August 5, 2014
Exclusive Use of Alternative Medicine as a Positive Choice: A Qualitative Study of Treatment Assumptions Among People with Multiple Sclerosis in Denmark
A Pooled Analysis of Two Phase 3 Clinical Trials of Dalfampridine in Patients with Multiple Sclerosis
Andrew D. Goodman, Theodore R. Brown, Randall T. Schapiro, Michael Klingler, Ron Cohen and Andrew R. Blight
Effects of Functional Electrical Stimulation on Gait Function and Quality of Life for People with Multiple Sclerosis on Ampyra
R. Philip Kinkel, Genevieve Laforet and Xiaojun You
Informing the Children When a Parent Is Diagnosed with Multiple Sclerosis
August 1, 2014
The Disability Treaty
will be back!
You and thousands of other advocates around the country have been working tirelessly towards ratification – we salute your hard work on this crucial issue!
Though a floor time was not possible before the August recess, we look forward to new opportunities in September!
IT’S NOT OVER UNTIL IT’S OVER!
In the Foreign Relations Committee, RepublicanSenator John Barrasso of Wyoming included three amendments:
* An understanding that the CRPD will NOT affect the rights of parents to homeschool their children.
* An understanding that nothing in Article 7 regarding children with disabilities requires changes in U.S. law
* An understanding of the limited scope of the CRPD committee’s authority
These address the concerns of the opposition moving forward!
We’ll be back to you soon with more information!
Visit our citizen action portal,www.disabilitytreaty.org to stay informed and take action!
July 30, 2014
Scientists at The New York Stem Cell Foundation (NYSCF) Research Institute are one step closer to creating a viable cell replacement therapy for multiple sclerosis from a patient’s own cells. Read full article at: http://www.medicalnewstoday.com/releases/280179.php?tw
Biogen Idec has announced that the European Commission (EC) has granted marketing authorization for PLEGRIDYTM (peginterferon beta-1a) as a treatment for adults with relapsing-remitting multiple sclerosis(RRMS), the most common form of multiple sclerosis (MS). PLEGRIDY is dosed once every two weeks and is administered subcutaneously with the PLEGRIDY PEN, a new ready-to-use autoinjector, or a prefilled syringe. Read full article at: http://www.medicalnewstoday.com/releases/280200.php?tw June 2014
SUCCESSFUL ANNUAL MEETING
OF CMSC & ACTRIMS
June 4, 2014
Highlights from the American Academy of Neurology’s Annual Meeting
The American Academy of Neurology’s (AAN’s) 66th Annual Meeting took place in Philadelphia, Pennsylvania April 26th-May 3rd. The AAN is an association of more than 27,000 neurologists and neuroscience professionals dedicated to advancing the care of individuals with neurologic disease. Every year, these professionals gather to hear the latest findings in research and treatments for neurological conditions, including multiple sclerosis (MS). To follow are some important highlights.
Complete article: http://mymsaa.org/news-msaa/1123-aan-highlights-2014 March 14, 2014 News from National MS Society
The Affordable Care Act and Prescription Drug Coverage
- The ACA requires all new health plans sold to individuals and small groups to cover ten “Essential Health Benefits” including prescription drugs.
- Many Marketplace and Exchange plans include limited formularies with tiered drug benefits, prior authorization, and/or other control measures. These features are commonly found in most health plans, including ones that existed before implementation of the ACA.
- Health insurers have traditionally been free to determine which prescription drugs they would and would not cover; the ACA continues to leave control over drug formularies and cost control measures (e.g., prior authorization and ‘first fail’ requirements, quantity limits, and tiered formularies) in the hands of the health insurers.
- Formulary exclusions and cost control measures have and will continue to impact patient access to needed medications, coverage and out-of-pocket costs.
- The ACA limits out-of-pocket costs (deductibles, co-pays and co-insurance) for all essential health benefits to $6,350 for individuals, and $12,700 for couples and families in 2014. Read more.
- Since many of the new Marketplace and Exchange plans include limited formularies with tiered drug benefits, prior authorization and/or other control measures, people with MS should carefully review formularies before purchasing a plan through the Marketplace.
- The Society advocates for reasonable measures to minimize the impact of formulary exclusions and limitations at both the federal and state levels.
January 29, 2014 “New Copaxone Dosing Approved for Fewer Injections” (from MSAA) Teva Pharmaceutical Industries Ltd. announced that the new, three-times-per-week dosing of Copaxone® (glatiramer acetate), at a higher dose of 40 mg, has been approved by the FDA. Daily Copaxone at the traditional 20-mg dose will also continue to be available. If prescribed by one’s doctor, the new formulation enables individuals who take Copaxone to reduce their number of subcutaneous injections from seven times to three times per week.
December 2013 Highlights from the ECTRIMS 29th Congress International Meeting (2013)
June 2013 Multiple Sclerosis News
Medical News Today – http://www.medicalnewstoday.
|Multiple Sclerosis News|
|MS Treatment That Resets Immune System Shows Promise In Safety Trial A new treatment for multiple sclerosis (MS) that resets the patient’s immune system was found to be safe and well tolerated in a small trial published in Science Translational Medicine this week.|
|Multiple Sclerosis News|
|Biogen Idec Submits Application To FDA For Approval Of Plegridy™ (Peginterferon Beta-1a) In Multiple Sclerosis EMA Submission Planned in the Coming WeeksBiogen Idec (NASDAQ: BIIB) has announced it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for approval of PLEGRIDY™ (peginterferon beta-1a), the company’s pegylated subcutaneous injectable candidate for relapsing forms of multiple sclerosis (RMS).|
Has Natural Selection Caused Inflammatory Disease?
In new research published in the April 4, 2013 issue of The American Journal of Human Genetics, researchers from Brigham and Women’s Hospital (BWH) demonstrate that some variants in our genes that could put a person at risk for inflammatory diseases such as multiple sclerosis, Crohn’s disease or rheumatoid arthritis, have been the target of natural selection over the course of human history. The research team, led by Philip De Jager, MD, PhD, BWH Department of Neurology, and Barbara Stranger, PhD, University of Chicago looked at genome-wide association studies along with protein-protein interaction networks, as well as other data and found 21 places in the genome that bear a ‘signature’ for both inflammatory disease susceptibility and natural selection. Towfique Raj, PhD, BWH Department of Neurology, is the lead author on this study. The findings suggest that in the past these variants rose in frequency in the human population to help protect us against viruses, bacteria and other pathogens. But now in our modern world, the environment and exposure to pathogens has changed, and the genetic variants that were originally meant to protect us, now make an autoimmune reaction more likely. These results are consistent with the hygiene hypothesis in which our cleaner environment is thought to contribute to the increasing prevalence of inflammatory diseases. December 3, 2012 Full manuscript can be found at: http://www.cell.com/AJHG/abstract/S0002-9297(13)00109-2 Brigham and Women’s Hospital
|Elevated Levels Of Vitamin D During Pregnancy May Prevent Multiple Sclerosis In Mothers High levels of Vitamin D in the blood could prevent multiple sclerosis (MS) in mothers, more so than in babies, according to a new study published in the journal Neurology. Study author Jonatan Salzer, MD and neurologist at UmeÃ¥ University Hospital says:”In our study, pregnant women and women in general had a lower risk for MS with higher levels of the vitamin, as expected.|
|In Mouse Model Of Multiple Sclerosis, Experimental Drug Improves Memory Johns Hopkins researchers report the successful use of a form of MRI to identify what appears to be a key biochemical marker for cognitive impairment in the brains of people with multiple sclerosis (MS).|
|Scientists Develop New Treatment To Combat Autoimmune Disease In Mouse Model In a mouse model of multiple sclerosis (MS), researchers funded by the National Institutes of Health have developed innovative technology to selectively inhibit the part of the immune system responsible for attacking myelin – the insulating material that encases nerve fibers and facilitates electrical communication between brain cells.|
Nanoparticles Stop Multiple Sclerosis In Mice A breakthrough new experimental treatment that uses nanoparticles covered with proteins to trick the immune system, managed to stop it attacking myelin and halt disease progression in mice with relapsing remitting multiple sclerosis (MS). Study Shows How Social Isolation Disrupts Myelin Production Animals that are socially isolated for prolonged periods make less myelin in the region of the brain responsible for complex emotional and cognitive behavior, researchers at the University at Buffalo and Mt.
- Re-Educating Immune Cells May Halt MS Progression
- Tracking Culprit B Cells May Lead to New Treatment
- Blocking Enzyme May Allow Remyelination
- New Tool May Help Speed Diagnosis
- MSF’s 12th Annual Cruise for a Cause Returns to Alaska
- Research Participants Needed for a Phenomenological Study
- Clinical Trial
- Proposals to Implement Provisions in Health Care Law
- Website to Watch
November 8, 2012 Visit www.neurologyreviews.com for free full-text news articles on current research findings in neurology. Our website also features an archive of selected news articles. New Light Shed On Nerve Fibres In The Brain By MRI Research Discovery Could Be ‘Life-Changer’ For Millions With MS, Stroke And Other Conditions That Cause Brain Damage “Rebooting” MS Drug Succeeds In Trials Repair Of Multiple Sclerosis Brain Damage May Be Possible New MS Drug Proves Effective Where Others Have Failed A drug which ‘reboots’ a person’s immune system has been shown to be an effective treatment for multiple sclerosis (MS) patients who have already failed to respond to the first drug with which they were treated (a ‘first-line’ therapy), as well as affected individuals who were previously untreated For more information on WebMD’s mobile products, please visit us at http://www.webmd.com/mobile. November 1, 2012
- More Medicare Coverage May Soon Help Those with MS
- Quantifying MS Genetic Susceptibility
- Study Links Low Vitamin D Levels to Worse MS Symptoms
- MS Drug Costs Predicted to Continue Rising
- Infertility Treatments May Significantly Increase MS Activity
- New Dosing for Copaxone
- Reproduction B10 Cells Help Suppress Immune Responses
- MSF’s 12th Annual Cruise for a Cause Returns to Alaska
- Clinical Trial
- Website to Watch
NEW INFORMATION ABOUT MULTIPLE SCLEROSIS
MS Pill Shows Promise In Reducing Relapses Two studies of a new pill for multiple sclerosis (MS) suggest it may reduce relapses and disability progression in people with the more common, relapsing-remitting form of the neurological condition, which accounts for around 85% of cases. Aubagio (teriflunomide) Approved For Multiple Sclerosis Treatment, FDA Aubagio (teriflunomide), a once-daily tablet for adults with relapsing forms of MS (multiple sclerosis), has been approved by the US Food and Drug Administration (FDA).According to experts, the Multiple Sclerosis prescribing market is worth $12 billion annually. FDA Approves Oral Teriflunomide – Brand Name Aubagio® – as Disease-Modifying Therapy for Relapsing MS User Options: .Sep 12, 2012 Updated FAQs 9/14/12 The U.S. Food and Drug Administration has approved teriflunomide once-daily pills (Aubagio,® Genzyme, a Sanofi company) to treat relapsing forms of MS. This is the second oral disease-modifying therapy approved for the treatment of multiple sclerosis. The therapy is expected to be available for prescription by October 1, 2012 in the U.S. The company has also applied for regulatory approval in other parts of the world. “We are greatly encouraged to see a new oral therapeutic option become available to people living with MS,” advised Bruce A. Cohen, MD, Professor, Davee Department of Neurology and Clinical Neurosciences at Northwestern University’s Feinberg School of Medicine, and incoming Chair of the National MS Society’s National Medical Advisory Committee. “As with any new therapy, the long-term safety of Aubagio will need to be carefully monitored,” he added. Dr. Timothy Coetzee, Chief Research Officer at the National MS Society agreed. “With the collaborative research underway around the world today, this is an extremely hopeful time for anyone who is diagnosed with MS.” Read the FDA’s press release. About Teriflunomide/Aubagio: Multiple sclerosis involves immune system attacks on the brain and spinal cord. Aubagio (pronounced oh-BAH-gee-oh) is a novel oral compound that inhibits the function of specific immune cells that have been implicated in MS. It is related to leflunomide, a drug used to treat arthritis. Aubagio can inhibit a key enzyme required by white blood cells (lymphocytes), reducing the proliferation of T and B immune cells active in MS and also inhibiting the production of immune messenger chemicals by T cells. It is not thought to affect resting immune cells that are not in an activated state. Two doses (7mg and 14 mg) have been approved. Potential benefits: Three large clinical trials of Aubagio have been completed, and at least two more are ongoing. In the phase III TEMSO study, Aubagio reduced the average number of MS relapses and disease activity on MRI scans significantly more than inactive placebo in 796 people with relapsing forms of MS. Read more about this study. In a recently completed phase III TOWER study involving 1,169 people with relapsing-remitting MS, oral Aubagio reduced relapses compared with placebo over at least 48 weeks, according to a company press release. Of two different doses tested during the TOWER trial (7 mg and 14 mg), the higher dose also slowed progression of disability. Read more about this study. In another study, called TENERE, Aubagio was compared with Rebif® (interferon beta-1a, EMD Serono and Pfizer) in relapsing MS, and did not reach its primary endpoint (the main question posed by the study) — the “risk of failure,” meaning the first occurrence of a relapse, or permanent discontinuation of the study treatment, whichever came first. There was no significant difference in the numbers of participants who experienced events defined as treatment failure among the Aubagio and Rebif groups. Potential risks and screenings: In trials to date, Aubagio was generally safe and well tolerated. The most common side effects experienced by participants in clinical trials include diarrhea, abnormal liver tests, nausea, flu, and hair thinning. The prescribing information includes a boxed warning related to the potential for liver damage in persons taking Aubagio. There is also a warning that Aubagio is not indicated for women who are pregnant or women with childbearing potential who are not using reliable contraception. The prescribing information also contains information on how to clear Aubagio from the system in case that is required. Before people begin taking Aubagio, they should have a blood test, of have had one within six months, to detect levels of liver enzymes and levels of blood cells (Complete Blood Count). They should also have their blood pressure checked, and have a screening test for tuberculosis (tuberculin skin test). It should be verified in women of childbearing potential that they are not pregnant before taking Aubagio. After starting Aubagio, blood tests to detect liver enzymes should be done at least monthly for the first six months, and then patients should be monitored for signs of liver damage. Patients should also be monitored for signs of infection, and blood pressure should be checked periodically. Taking a disease-modifying therapy is currently the best way to reduce MS disease activity and future deterioration. Selecting an MS therapy should be done by people with MS in collaboration with their MS doctors, taking into account a variety of factors, including the effectiveness of any therapy they are currently using, and weighing potential risks and benefits, costs and lifestyle factors. Physicians and people with MS can contact Genzyme for information about Aubagio and patient support programs by calling: 1-855-676-6326, or visit the company’s Website: www.MSOnetoOne.com. Download the Prescribing Information and Medication Guide (.pdf) Read more about disease-modifying therapies and other treatments for MS and MS symptoms Read about National MS Society efforts to speed research in progressive MS
FAQ About FDA’s Approval of Oral Teriflunomide – Brand name Aubagio – for Relapsing MS
Updated with additional questions 9/14/12 Q. What is Aubagio? A. Aubagio is a small molecule that inhibits the function of specific immune cells that have been implicated in MS. It is related to leflunomide, a drug used to treat arthritis. Aubagio can inhibit a key enzyme required by white blood cells (lymphocytes), reducing the proliferation of T and B immune cells active in MS and also inhibiting the production of immune messenger chemicals by T cells. It is not thought to affect resting immune cells that are not in an activated state. Q. What types of MS is Aubagio approved to treat? A. The FDA has approved Aubagio for the treatment of patients with relapsing forms of MS (http://www.nationalmssociety.org/about-multiple-sclerosis/relapsing-ms/index.aspx). In other words, people who experience periodic MS attacks, such as those who have relapsing-remitting MS or secondary-progressive MS with relapses. Q. How is Aubagio taken? A. The pill is taken orally once per day. Q. When will Aubagio be available by prescription? A. Aubagio is expected to be available by prescription by October 1, 2012. Q. How effective is Aubagio? A. Results from three phase III studies have been released. For the TOWER trial, 1,169 people with relapsing MS were randomly assigned to receive Aubagio 7 mg or 14 mg, once daily by mouth, or inactive placebo, for 48 weeks. According to a company press release, Aubagio 14 mg (the dose approved by the FDA) reduced relapses by 36.3% versus placebo. In the 14 mg-group, the time to disability progression was reduced by 31.5%. In the TEMSO trial, 1088 people with relapsing MS were randomly assigned to receive 7 mg or 14 mg of Aubagio, or inactive placebo for 108 weeks; 796 (73.2%) completed the study. After two years, both doses of Aubagio significantly reduced the average number of relapses in a year by as much as 31.5% over placebo. Fewer of those on the higher dose (14mg) experienced progression of disability compared with those on placebo (20.2% progressed on therapy vs. 27.3% on placebo). On imaging scans, the total volume of tissue damage and active areas of damage were reduced significantly more in both Aubagio groups than in the placebo group. For the TENERE trial, 324 people with relapsing MS were randomly assigned to receive Aubagio 7 mg or 14 mg, or Rebif® (interferon beta-1a, EMD Serono Inc. and Pfizer) 44 mcg three times per week subcutaneously for 48 weeks. The primary endpoint was “risk of failure,” meaning the first occurrence of a relapse, or permanent discontinuation of the study treatment, whichever came first. There was no significant difference in the numbers of participants who experienced events that constituted the definition of treatment failure among the Aubagio and Rebif groups, according to a company press release. Relapse rates did not differ significantly either. Q. What are the potential side effects of Aubagio? A. Aubagio may cause diarrhea, nausea, hair thinning, back pain, abnormal liver tests, flu, and lowered levels of white blood cells, which can increase the potential for infections. It can also increase blood pressure. The prescribing information includes a boxed warning related to the potential for liver damage in persons taking Aubagio. There is also a warning that Aubagio is not indicated for women who are pregnant or women with childbearing potential who are not using reliable contraception. The prescribing information also contains information on how to clear Aubagio from the system in case that is required. The Prescribing Information and Medication Guide (.pdf) provides full information on potential side effects, and signs that may indicate a problem. Q. What if I am taking Aubagio and I plan to become pregnant? A. A woman taking Aubagio who plans to become pregnant should stop taking the drug, continue using effective birth control, and undergo one of the treatment regimens designed to remove the drug from their systems quickly. Your doctor should ensure that blood levels of Aubagio are low enough before you stop using birth control. Q. What if I am taking Aubagio and I accidentally become pregnant? A. If you become pregnant while taking Aubagio (or within two years of stopping Aubagio), stop taking Aubagio and talk to your doctor right away. You should undergo one of the treatment regimens designed to rapidly remove the drug from your system, and consult with an obstetrician regarding potential harm to the fetus. Q. What if I am a man taking Aubagio and there is a chance my partner could become pregnant? A. Men should stop taking Aubagio if they plan to father a child, and they should contact their healthcare provider to undergo one of the treatment regimens designed to remove the drug from their systems quickly. If a man’s female partner does not plan to become pregnant, both of you should use effective birth control while you are taking Aubagio. Aubagio remains in your blood as long as two years after you stop taking it, so continue to use effective birth control until Aubagio blood levels have been checked and are low enough. Q. Should I switch from my current therapy to Aubagio? A. The decision about whether to take Aubagio should be made in collaboration with your MS doctor, taking into account a variety of factors including the effectiveness of any therapy you are currently using, the potential risks and benefits, as well as costs and lifestyle factors. Important questions to be considered and discussed with your doctor in terms of Aubagio include: • How am I doing on my current therapy? • What is my tolerance for the risk of known side effects? • What is my tolerance for the risk of adverse consequences that might emerge with longer-term use? • How will my medication choice affect my ability or plans to become pregnant? • What are the comparative costs of my current therapy versus Aubagio? Q. How does the effectiveness of Aubagio compare to other available therapies? A. Clinical trial results to date suggest that Aubagio has effectiveness against MS relapses in a similar range as the first generation disease-modifying therapies (interferons and glatiramer acetate). Aubagio has not been compared to all other available therapies, but in a comparison trial against Rebif, there were not significant differences in the outcomes tested. Q. How long would a person take Aubagio? A. There is no specified time limit for taking Aubagio. Q. Will a person taking Aubagio have to get any special medical tests or monitoring? A. Before people begin taking Aubagio, they should have a blood test, of have had one within six months, to detect levels of liver enzymes and levels of blood cells (Complete Blood Count). They should also have their blood pressure checked, and have a screening test for tuberculosis (tuberculin skin test). It should be verified in women of childbearing potential that they are not pregnant before taking Aubagio. After starting Aubagio, blood tests to detect liver enzymes should be done at least monthly for the first six months, and then patients should be monitored for signs of liver damage. Patients should also be monitored for signs of infection, and blood pressure should be checked periodically. Q. What are some symptoms of liver problems? A. People taking Aubagio should call their healthcare provider immediately if they have any of these symptoms of liver problems: nausea, vomiting, stomach pain, loss of appetite, tiredness, yellow tinge to the skin or whites of the eyes, or dark urine. Q. What are some symptoms of infection? A. People taking Aubagio should tell their healthcare provider if they have any of these symptoms of infection: fever, unusual tiredness, body aches, chills, nausea, vomiting. Q. What will Aubagio cost? A. The price has not been announced, but the actual cost to an individual who has MS will depend on the provisions of his or her insurance coverage and the degree to which that individual will be eligible for programs designed to assist with out-of-pocket costs. Q. Will my health insurance cover Aubagio? A. Coverage will depend on individual insurance plans. Q. Where can I get information about the support that Genzyme will provide to help patients? A. For more information about support services provided by Genzyme, people can call the company’s MS One To One line at: 1-855-676-6326, or visit the company’s Website: www.MSOnetoOne.com. Q. Did the National MS Society support the research and development of Audagio? A. No. Although the Society was not involved in the development of this treatment, the application of this drug to MS was made possible by the Society’s substantial investments in discovery research projects that helped define the immune pathways involved in MS disease activity. Q. Are there other oral disease-modifying therapies available or in development for MS? A. Yes, there are other oral therapies available now or in development. Gilenya is an oral therapy approved for relapsing MS forms of MS to reduce the frequency of clinical relapses and to delay the accumulation of physical disability. Others are in development. Oral BG12 (sponsored by Biogen Idec), for relapsing MS, is currently being reviewed by the FDA for marketing approval. Another oral therapy in later stages of development for relapsing MS is laquinimod (sponsored by Teva Pharmaceutical Industries). Read more about ongoing clinical trials in MS Q. I’ve been hearing news about other new treatments in development for MS. What are some details? A. Oral and infrequent-dose disease-modifying therapies are just two of many exciting research avenues that address ways to stop MS progression, restore function and end MS forever. Just a few new approaches being explored include potential benefits of the hormone estriol, adult stem cell transplantation, large-scale clinical trials for progressive MS, trials of agents aimed at protecting the nervous system, and studies of vitamin D and CCSVI (chronic cerebrospinal venous insufficiency). In addition, the newly formed International Collaborative on Progressive MS is a global effort to speed research and treatments on progressive MS. Q. Is Aubagio being tested in progressive MS? A. Not at this time. Q. Why aren’t there more treatments for progressive MS? A. Virtually every therapy approved for relapsing MS has been tested, or is now in testing, in people with progressive forms of the disease, including primary-progressive MS and secondary-progressive MS. Up to now, clinical trials involving people with relapsing MS often rely on counting relapses or doing MRI scans to detect immune activity. The fact that there is no easy way to detect progression quickly is one reason why drug development for progressive MS is behind. Right now there are large clinical trials going on in progressive MS, including tests of Tysabri,® Gilenya,® Ocrelizumab, and Masitinib. Download a table of trials on focusing on progressive MS (.pdf) Aubagio is a registered trademark of Genzyme, a Sanofi company Gilenya is a registered trademark of Novartis Rebif is a registered trademark of EMD Serono and Pfizer. Tysabri is a registered trademark of Biogen Idec and Elan Pharmaceuticals