Global Processing

Biogen, Acorda MS Drug Receives Conditional European OK

July 26, 2011

MarketWatch reports, Biogen Idec Inc. has received conditional approval of multiple sclerosis pill Fampyra in Europe, after a positive recommendation in May that followed an earlier rejection. The drug, developed by Acorda Therapeutics and licensed to Biogen for sales outside the U.S., is designed to improve walking by MS patients. It was approved in the U.S. last year under the name Ampyra. The conditional approval is renewable annually. Under terms of the decision, Biogen will gather data on the long-term effectiveness and safety of the drug, including its benefits beyond walking-speed improvements. The move is similar to accelerated approval by the U.S. Food and Drug Administration, which allows drugs on the market with the requirement to provide later data to gain full approval. Ampyra already has full FDA approval. European regulators recommended the approval in May, after Biogen appealed a January rejection by the Committee for Medicinal Products for Human Use, known as CHMP, of the European Medicines Agency, which questioned the effectiveness of the drug. Acorda will get a $25 million payment with the European approval and collect an increasing double-digit royalty.