News Center
Antibody Test Identifies New Risk Factor for PML
On January 20, 2012, the United States Food and Drug Administration (FDA) announced that three factors are now identified with increasing the risk of Progressive Multifocal Leukoencephalopathy (PML) for individuals with multiple sclerosis (MS) being treated with Tysabri® (natalizumab). PML is a potentially fatal brain infection with the JC virus (JCV), in people with weakened immune systems. The FDA has approved a labeling change, which adds the results of a newly approved test for the presence of anti-JCV antibodies, to the two previously listed risk factors.
MSAA Honored with a Web Health Award | MOBILE for My MS Manager™
The Multiple Sclerosis Association of America (MSAA ) is pleased to announce My MS Manager ™ , MSAA's mobile phone application, has been honored by the Web Health Awards | MOBILE with a Merit Award in the category of Mobile Application: Chronic Disease Management; Small Mobile Device in the Association/Professional Society/Non-Profit division.
European Agency Recommends Increased Monitoring with First Dose of Gilenya
The European Medicines Agency (EMA) announced that it has started a review of Gilenya (fingolimod) in response to reports of potential heart issues associated with the first dose of this drug.
Potential Drug Packaging Problem
The United States Food and Drug Administration (FDA) has notified the public that a packaging problem may have occurred with eight narcotic-type drugs (such as Opana®, Percocet®, and Endocet®), where a stray pill may have gone into another's packaging.
Gileyna News Update
Novartis Pharmaceuticals Corporation has informed the Multiple Sclerosis Association of America (MSAA) that a patient with multiple sclerosis (MS), who had been given one dose of Gilenya® (fingolimod), died on the following day. The individual's death occurred on November 23, 2011.
ECTRIMS Update 2011
This year's joint meeting of the European and Americas Committees for Treatment and Research in Multiple Sclerosis (ECTRIMS/ACTRIMS) was extremely well attended. More than 7,000 professionals attended the meeting, which featured more than 1,000 presentations - all in a whirlwind three-and-a-half days.
The following highlights review only a few of the many topics discussed at the meeting, but they reflect research of ongoing interest to the entire MS community.
FDA Launches Website on Safe Disposal of Used Needles
The United States Food and Drug Administration (FDA) recently announced that they have launched a new website (www.fda.gov/safesharpsdisposal ) devoted to information and instruction for the safe disposal of needles and other "sharps" used by individuals at home, work, and while traveling. In addition to standard needles and syringes, other dangerous medical supplies for disposal include items such as lancets or finger-stick devices for blood testing; needle and tubing systems, plus connection needles for hemodialysis at home.
CCSVI Update
Many questions still surround the possible connection between chronic cerebrospinal venous insufficiency (CCSVI) and multiple sclerosis (MS). This update provides an overview of CCSVI as well as a synopsis of information currently available.
Multiple Sclerosis Association of America Honored for Publication Excellence
The Multiple Sclerosis Association of America (MSAA) is pleased to announce awards for two of its publications:
• Daddy's Story - MSAA's children's book received a 2011 Magnum Opus Award for Outstanding Achievement in Custom Media (Bronze Award in the category of Nonprofit Publication, Best All Around) and a 2011 National Health Information Award (Merit Award) for Patient Education Information.
• The Motivator - The Winter/Spring 2010 issue of MSAA's magazine received a 2011 APEX Award for Publication Excellence in Magazine & Journal Writing.
Multiple Sclerosis Association of America and National Disability Institute Launch a Four-Part Webinar Series on Financial Wellness for the Multiple Sclerosis Community
The Multiple Sclerosis Association of America (MSAA) and National Disability Institute (NDI) are collaborating on a series of four free webinars designed to assist the MS community in learning about strategies to protect and improve their financial well-being.
Botox® Approved for Urinary Incontinence
On August 24, 2011, Allergan, Inc. announced that the United States Food and Drug Administration (FDA) approved Botox® (onabotulinumtoxinA) injection for the treatment of urinary incontinence. Specifically, the approval is for adults who experience "detrusor over-activity" resulting from a neurological condition, such as multiple sclerosis (MS) and who either do not respond adequately or are intolerant of anticholinergic medications.
Article Published on the Cost Effectiveness for Treating MS
Much attention has been focused on an article appearing in the July 26 issue of Neurology (vol. 77, pages 355-363) titled, "Cost-effectiveness of disease-modifying therapies for multiple sclerosis." This article presents the results of a study that looks at several factors in an effort to estimate the overall 10-year expense versus benefit associated with the long-term treatments for MS, in combination with other costs and lost wages.
Identifying and Meeting the Needs Associated with Primary-Progressive MS
An informative article on primary-progressive multiple sclerosis (PPMS) appears in the summer 2011 issue of the International Journal of MS Care. "Meeting the Needs of People with Primary Progressive Multiple Sclerosis, Their Families, and the Health-Care Community" is part of a collaborative project between the Multiple Sclerosis Association of America (MSAA) and the National Multiple Sclerosis Society (NMSS) to recognize the needs of this specific population and to create programs to help answer these needs.Merck Serono No Longer Seeking Approval of Oral Cladribine
Merck Serono announced on June 22, 2011 that they will no longer seek global approval for oral Cladribine. Cladribine tablets were expected to be one of the next approved disease-modifying therapies to treat relapsing forms of multiple sclerosis (MS).Multiple Sclerosis Association of America Launches Mobile Phone App for the MS Community
My MS Manager is the Multiple Sclerosis Association of America's new mobile phone application, provided free of charge to individuals with multiple sclerosis (MS) or their care partner to use on their iPhone, iPad or iPod touch. Developed in conjunction with Ringful Health, My MS Manager is available now for download in the Apple iTunes Store.
Multiple Sclerosis Emerging Therapies Collaborative
We are proud to announce the launch of the Multiple Sclerosis Emerging Therapies Collaborative. The Collaborative – which includes the members of the MS Coalition, the American Academy of Neurology, and the VA Multiple Sclerosis Centers of Excellence East and West – has as its mission:To develop and disseminate timely, evidence-based resources to persons affected by multiple sclerosis and health care professionals, in order to promote optimal, individualized treatment of the disease by facilitating effective communication and medical decision-making.
Oral Cladribine Denied FDA Aproval
EMD Serono, Inc., makers of Cladribine Tablets (an oral formulation of cladribine), announced today that they received a complete response letter (CRL) from the United States Food and Drug Administration (FDA). The FDA issues a CRL when it has completed the review of an application, but is not able to approve the application without additional information. The announcement was disappointing to members of the MS Community, who where hoping to see another option added to the list of available disease-modifying therapies for the long-term treatment of MS.
March is MS Awareness Month
The Multiple Sclerosis Association of America (MSAA) encourages everyone to take time this March to learn about multiple sclerosis (MS).
MSAA Survey Reveals Surprising Results: Involuntary Crying and Laughing is Reported by More People With MS than Expected
MS can impact not only physical and cognitive abilities, but also a person's emotional wellbeing. In cooperation with the research organization Infogroup/ORC and supported by an unrestricted educational grant from Avanir Pharmaceuticals, the Multiple Sclerosis Association of America (MSAA) conducted an independent, online survey of almost 20,000 of its members in the fall of 2010. The purpose of this survey was to better understand the extent and impact of a particularly challenging neurological condition known to occur among people living with MS: pseudobulbar affect (PBA).
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NEWS ALERT:Voluntary Recall of Potentially Contaminated Alcohol Prep Products Used with Injected Medications
Triad Group, a Wisconsin-based manufacturing company, is voluntarily recalling all lots of their alcohol prep pads, alcohol swabs, and alcohol swabsticks manufactured under their name (Triad Group), or under third party names (Cardinal Health, PSS Select, VersaPro, Boca/ Ultilet, Moore Medical, Walgreens, CVS, and Conzellin).These lots of alcohol prep products have been recalled as a result of potential contamination with Bacillus cereus-bacteria that could lead to life-threatening infections, particularly in those whose immune system is suppressed and for individuals undergoing surgery. As of January 5, 2011, Triad Group has received one report of a non-life-threatening skin infection.
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FDA Extends the Review Period for Oral Cladribine
Cladribine is an investigational oral drug being studied for the long-term treatment of relapsing forms of multiple sclerosis (MS). It was submitted to the United States Food and Drug Administration (FDA) for approval earlier this year, receiving Fast Track status in July 2010. Fast Track status reduces the FDA's review time from 10 months down to six – and a decision was expected by November 28, 2010. However, the agency has extended the review time by three months, with a decision now anticipated by February 28, 2011.
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FDA Approves Nuedexta to Treat Pseudobulbar Affect (PBA)
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Updated December 3, 2010*
On October 29, 2010, Avanir Pharmaceuticals, Inc. announced the approval of Nuedexta™ by the Food and Drug Administration (FDA) for the treatment of pseudobulbar affect (PBA) associated with certain neurological conditions, including multiple sclerosis (MS). PBA is characterized by uncontrolled, inappropriate, and/or exaggerated episodes of crying, laughing, or other emotional display. PBA occurs involuntarily with little or no stimulation to invoke such a response. It can greatly impact social situations and overall quality of life, both for the patient and his or her family.
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FDA Approves First Oral Treatment for Relapsing Forms of MS
Novartis Pharmaceuticals Corporation announced today that the United States Food and Drug Administration (FDA) has approved Gilenya (fingolimod) as a first-line treatment for relapsing forms of multiple sclerosis (MS). Gilenya is the first oral disease-modifying therapy available for the long-term treatment of MS. The approval of a treatment that may be taken orally (by mouth), versus injection or infusion, is exciting news for members of the MS community..
FDA Committee Recommends the Approval of FTY720
The oral medication FTY720 (fingolimod) has moved another step closer to approval as a new disease-modifying therapy for MS. The United States Food and Drug Administration (FDA) Peripheral and Central Nervous System Drugs Advisory Committee reviewed the clinical trial data submitted by Novartis Pharmaceuticals Corporation (makers of FTY720), and reported its findings at a meeting held on June 10, 2010.
Phase 2 CHOICE Study Reports Positive Effects with Daclizumab
Biogen Idec and Facet Biotech Corporation, developers of daclizumab, report that when added to an interferon regimen, this drug reduces the number of new or enlarged MS lesions in patients with active, relapsing forms of MS. Additionally, daclizumab showed an increase in the number of a certain type of cell that helps to regulate the immune system. These results were published in the online edition of The Lancet Neurology and in the April 2010 issue of The Lancet Neurology.
Continued Efficacy and Safety Seen with 15-Year Evaluation of Copaxone
In February 2010, Teva Pharmaceutical Industries Ltd. announced the publication of their data from 15 years of prospective and continuous evaluation of Copaxone®. The 15-year study findings appeared in the February 2010 issue of the journal, Multiple Sclerosis. Given the positive results, this study has been extended to 20 years, and is presently in its 19th year. Copaxone is given via daily subcutaneous injections and is approved for individuals with relapsing-remitting MS (RRMS).
Positive Study Results with Oral FTY720 Leads to Granting of Priority Review Status by FDA
In January 2010, the results from two large Phase III trials with oral FTY720 (fingolimod) were published in The New England Journal of Medicine. According to a press release from Novartis Pharmaceuticals Corporation (makers of FTY720), the TRANSFORMS and FREEDOMS studies showed positive results in reducing relapses, disability progression, and MRI lesions when MS patients were given FTY720.
FDA Approves Botox® for the Treatment of Upper Extremity Spasticity
The United States' Food and Drug Administration (FDA) has approved Botox® (onabotulinumtoxin A) for the treatment of spasticity in the flexor muscles of the elbow, wrist, and fingers in adults. Manufactured by Allergan, Inc., this drug is administered via injection by a medical professional and is available through prescription only.
