EMA CHMP issues negative opinion against Biogen Idec's FAMPYRA for multiple sclerosis

Biogen Idec (NASDAQ: BIIB) announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a negative opinion recommending against approval of FAMPYRA® (prolonged-release fampridine 10 mg tablets) to improve walking ability in adult patients with multiple sclerosis (MS) in the European Union. Biogen Idec intends to appeal this opinion and request a re-examination of the decision by the CHMP.

"About two-thirds of MS patients report difficulty in walking due to their disease, and currently there is no therapy approved in Europe to address this high unmet medical need," said Alfred Sandrock, M.D., Ph.D., Head of Neurology Research & Development at Biogen Idec. "Tens of thousands of people with MS have already received the therapy in the United States, where it is approved, and many have reported important benefits. We will work closely with the CHMP during the appeal process to address the Committee's concerns, with the goal of making this important medication available to MS patients in Europe."

As a leader in MS with two MS medications on the market and six potential MS therapies in the pipeline, Biogen Idec has significant scientific expertise in MS and is committed to improving the lives of patients living with this disease.

As of the end of September 2010, approximately 6300 prescribers had initiated approximately 31,000 MS patients on prolonged-release fampridine tablets treatment in the United States (U.S.), where the drug is commercialized by its developer, Acorda Therapeutics, Inc., under the trade name AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg. AMPYRA was approved by the U.S. Food and Drug Administration on January 22, 2010.

For further details about the CHMP opinion on FAMPYRA, please visit the EMA website www.ema.europa.eu/ema.

SOURCE Biogen Idec

Comments

The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
Post a new comment
Post
You might also like...
Study reveals the various ways patients with multiple sclerosis acquire disability