New MS Drug Hits Delay (ACOR, BIIB)

October 22, 2009 · Filed Under fda, multiple sclerosis 

Acorda Therapeutics, Inc. (NASDAQ: ACOR) announced this morning that the FDA has extended its review period of the company’s Fampridine-SR as a multiple sclerosis treatment.  The PDUFA goal date was moved out to January 22, 2010 for its review of the New Drug Application. The original date for the priority review was October 22, 2009.

Following the Peripheral and Central Nervous System Drugs Advisory Committee meeting, Acorda said that it has submitted additional information on its proposed risk evaluation and mitigation strategy program. It further noted that the FDA accepted this submission as a solicited major amendment to the new drug application.

The FDA can extend the PDUFA goal date when a sponsor submits a major amendment that provides a substantial amount of new data not previously reviewed by the FDA.

The good news for Acorda is that this does not appear to derail the ultimate approval.  This one has been very volatile based upon an FDA comment period followed by a panel recommendation that gave the stock its mojo back.
As a reminder, Biogen Idec Inc. (NASDAQ: BIIB) is the multiple sclerosis benchmark company in the sector.  Any real delays or ultimate changes to an application policy allow Biogen’s Avonex and TYSABRI that much more leading time.

JON C. OGG
OCTOBER 22, 2009

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