FDA extends review of Acorda's Fampridine-SR

Acorda Therapeutics Inc. (NASDAQ:ACOR) said FDA extended the PDUFA date for an NDA for Fampridine-SR to improve walking ability in patients with multiple sclerosis by three months to Jan. 22 from Oct. 22. Acorda said it submitted additional information on its proposed risk evaluation and mitigation strategy (REMS) program after last week's FDA advisory committee meeting on the sustained-release formulation of 4-aminopyridine (4-AP). FDA accepted the submission as a major amendment to the NDA. The Peripheral and Central Nervous System Drugs Advisory Committee supported approval of Fampridine-SR (See BioCentury, Oct. 19, 2009). ...