New Dosing Regimen for Copaxone Submitted to FDA

Teva Pharmaceuticals Industries, Ltd., the makers of Copaxone® (glatiramer acetate), announced on May 30, 2013 that the United States Food and Drug Administration (FDA) had accepted a supplemental new drug application (sNDA) for Copaxone at a higher dose and reduced frequency. The present FDA-approved dose of Copaxone is 20 mg given daily via subcutaneous injection. The new dosing under review is double the concentration (40 mg) and is given three days per week (also via subcutaneous injection) versus every day. If FDA approved, a less-frequent treatment option for Copaxone may become available.

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Biogen Idec Submits a New MS Treatment to FDA for Approval

UPDATE: On July 19, 2013, Biogen Idec announced that the United States Food and Drug Administration (FDA) had accepted their application for the marketing approval of Plegridy&#0153 in the United States. The FDA will review the drug under its standard review timeline. The European Medicines Agency (an agency in Europe similar to the FDA in the United States) is also reviewing an application for the approval of Plegridy in the European Union. On May 21, 2013, Biogen Idec submitted a new treatment for multiple sclerosis (MS) to the United States Food and Drug Administration (FDA) for approval. This potential new disease-modifying therapy (DMT) for the long-term treatment of MS is a pegylated version of interferon beta-1a. Using the brand name of “Plegridy&#0153,” if approved, this new product would require fewer injections than the other presently approved self-injectable DMTs for MS.

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Highlights from the American Academy of Neurology’s Annual Meeting

The American Academy of Neurology’s (AAN) 65th Annual Meeting took place in San Diego, California in March. This large medical conference presents the latest findings in research and treatments for neurological conditions, including multiple sclerosis (MS). To follow are some important highlights.

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PML Reported in Psoriasis Patients Taking Fumaric Acid Medications in Europe

Two cases of progressive multifocal leukoencephalopathy (PML) in individuals taking either fumaric acid or a compound of fumaric acid esters were reported in The New England Journal of Medicine (N Engl J Med 2013;368;17:1657-1660) on April 25, 2013. PML is a potentially fatal brain infection with the JC virus (JCV), in people with weakened immune systems. Both of these reports were from Europe in individuals receiving long-term treatment for psoriasis (a chronic skin problem that causes skin cells to grow too quickly, resulting in thick, white, silvery, or red patches of skin [WebMD]).

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Tecfidera Approved for the Long-Term Treatment of MS

The United States Food and Drug Administration (FDA) announced on March 27, 2013 that it has approved Tecfidera™ (dimethyl fumarate or DMF, formerly known as BG-12) as a first-line therapy for the long-term treatment of relapsing forms of multiple sclerosis (MS). Tecfidera’s parent company, Biogen Idec, submitted a New Drug Application (NDA) to the FDA for the approval of this drug in February 2012. (Read the FDA’s press release on the approval of Tecfidera.)

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March is MS Awareness Month

The Multiple Sclerosis Association of America (MSAA) recognizes March as MS Awareness Month. Throughout March, MSAA encourages individuals to expand their knowledge, understanding, and support of individuals whose lives are affected by multiple sclerosis (MS).

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The Multiple Sclerosis Association of America Launches New Website

The Multiple Sclerosis Association of America (MSAA) is pleased to introduce its new website, mymsaa.org.

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Multiple Sclerosis Association of America Teams Up With SwimOutlet.com To Promote Swim For MS

The Multiple Sclerosis Association of America (MSAA) is pleased to announce its new partnership with SwimOutlet.com to help promote the charity’s national fundraiser, Swim for MS. Serving as the distribution sponsor for Swim for MS, SwimOutlet.com will feature promotional information and ongoing updates on swim events through newsletter articles, targeted email campaigns, and posts on social media including Facebook and Twitter.

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Flu and Flu Vaccine Information

Recent news reports and statistical information indicate that this year the incidence rate for seasonal influenza (flu) is already high and is widely impacting communities across the nation. The good news is that the flu immunization prepared for the 2012-2013 flu season appears to be very well matched to those flu strains occurring across the country; therefore, preventative measures such as obtaining a flu vaccine may be helpful in preventing the contraction of the flu.

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MSAA’s Mobile Phone App Launches in the Android Marketplace

My MS Manager™, the first-of-its-kind mobile phone application developed to help individuals better manage their MS, is now available on the Android platform. Since its launch in the Apple App Store in June of 2011, My MS Manager has been downloaded more than 9,000 times, with users entering data about their MS on various Apple mobile products.

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