ARTICLE | Clinical News

Fampyra fampridine regulatory update

August 1, 2011 7:00 AM UTC

The European Commission granted conditional approval to an MAA from Biogen Idec for Fampyra fampridine to improve walking ability in patients with multiple sclerosis (MS) who have walking disability. As part of conditional approval, Biogen Idec will conduct a long-term study of Fampyra to evaluate the drug's benefits beyond its effect on walking speed. Conditional approval is renewable annually. Biogen Idec plans to launch the sustained-release formulation of 4-aminopyridine beginning in Germany in September.

The approval triggers a $25 million milestone payment to Acorda, which granted Biogen Idec rights outside the U.S. Acorda, which has worldwide rights from Elan, launched the product as Ampyra dalfampridine in the U.S. last year. ...