lohud.com

Sponsored by:

Business in the Burbs

Movers, shakers and newsmakers

Acorda drug eligible for coordinated review in Europe

June
8

Acorda Therapeutics Inc. said that its new multiple sclerosis drug is eligible for a centralized regulatory review in Europe, potentially opening up huge new markets for the medication if it receives approval.

The Hawthorne-based biotech company has been seeking approvals for the drug, known as Fampridine-SR, after a study showed that patients taking the medication walked faster than patients taking a placebo.

Multiple sclerosis is a chronic nervous-system disease in which the immune system attacks nerve fibers in the brain and spinal cord. If the drug is approved, the drug could one day make walking easier for the multiple sclerosis victims who deal with mobility problems.

Acorda said that European regulators have decided that the drug can be evaluated in a single, coordinated review on behalf of all European Union member countries, instead of the time consuming process of each country doing the evaluation seperately. Acorda could gain a 10-year market exclusivity for Fampridine-SR in European Union countries under the approval process.

Acorda is also seeking approval to market the drug in the United States from the U.S. Food and Drug Administration.

This entry was posted on Monday, June 8th, 2009 at 3:55 pm by Jay Loomis. You can follow any responses to this entry through the RSS 2.0 feed.
Category: Biopharmaceutical

|

Advertisement

Advertisement
About this blog
Business in the Burbs is our online news blog about businesses based or operating in the Lower Hudson Valley. Visitors here will also find items of interest to consumers in the region. Most contributions are from business reporters and editors covering Westchester, Rockland and Putnam counties.

Subscribe

Get blog updates via email:




About the Authors

Categories

Other recent entries




Links

Monthly Archives