News Center
FDA Issues CCSVI Treatment Warning
On May 10, 2012, the United States Food and Drug Administration (FDA) issued a warning about experimental therapies aimed at treating chronic cerebrospinal venous insufficiency (CCSVI). This is a complex condition involving changes in blood flow from the brain back to the heart, caused by the twisting or collapse of certain veins located on the outside of the brain.
New Prescribing Information for Gilenya
On April 20, 2012, Novartis announced changes to the prescribing information for Gilenya™ (fingolimod) in the treatment of relapsing forms of multiple sclerosis (MS). This new prescribing information is applicable only to individuals who have not been given a first dose of Gilenya or for those who have stopped and will be restarting the drug. These changes do not affect any guidelines for individuals who are currently taking Gilenya.
Awaiting FDA Review: MS Patient with PML on Gilenya after Tysabri
Novartis released a safety information update on April 13, 2012 stating that an individual with MS who was taking Gilenya (fingolimod) was diagnosed with progressive multifocal leukoencephalopathy (PML). This infection of the brain has been associated with another treatment for MS, Tysabri® (natalizumab). Depending on the risk factors discussed below, a small number of MS patients may develop PML either while taking Tysabri or up to three months after discontinuing this drug.
March is Multiple Sclerosis Awareness Month
The Multiple Sclerosis Association of America (MSAA) is pleased to recognize March as MS Awareness Month. During the month of March, MSAA will be highlighting various programs designed to expand knowledge, understanding, and support of individuals whose lives are affected by multiple sclerosis (MS).
FDA Approves Avonex Pen™ and Initial Dosing Regimen
Biogen Idec announced last week that the United States Food and Drug Administration (FDA) has approved both a new device (the Avonex Pen) as well as a new dosing regimen for Avonex (interferon beta-1a). These two approvals are aimed at assisting patients who are either taking Avonex presently, or who are just starting Avonex, for the treatment of relapsing forms of multiple sclerosis (MS).
Biogen Idec Submits Application to FDA for BG-12
Biogen Idec announced last week that they have submitted an application to the United States Food and Drug Administration (FDA) for approval of BG-12 (dimethyl fumarate), an experimental oral drug for the treatment of relapsing-remitting multiple sclerosis (RRMS). The company plans to also submit an application for the same drug to the European Medicines Agency (EMA) shortly. Biogen Idec expects to hear back from these two agencies within a few months regarding the status and potential approval of BG-12.
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.
