European Commission gives conditional OK for Biogen Idec's MS drug Fampyra

The European subsidiary of US biotech firm Biogen Idec (Nasdaq: BIIB) has received conditional approval from the European Commission for Fampyra (prolonged-release fampridine tablets) to improve walking in adult patients with multiple sclerosis (MS) who have walking disability (Expanded Disability Status Scale 4-7). Fampyra will be available in Europe, on a country-by-country basis, beginning with Germany in September 2011, with other countries following.

Fampyra is the first treatment that addresses this unmet medical need with demonstrated efficacy in people with all types of MS. It can be used alone or in combination with disease modifying therapies, including immunomodulatory drugs. Following a re-examination of its previous negative opinion on the drug, the European Medicines Agency’s advisory committee recently recommended conditional approval (The Pharma Letter May 23).

Further study on long-term safety requested