|Acorda Therapeutics (NASDAQ:ACOR) questioned by FDA|
|By Staff and Wire Reports|
|Friday, 09 October 2009 09:58|
Acorda Therapeutics (NASDAQ:ACOR) is dropping, after the FDA questioned the efficacy of the company's Amaya drug.
Acorda had announced that the U.S. Food and Drug Administration (FDA) has posted on its website briefing documents for the Peripheral and Central Nervous System Drugs Advisory Committee meeting to review Acorda’s New Drug Application (NDA) for Fampridine-SR for the proposed indication of improvement of walking ability in people with multiple sclerosis (MS). The Prescription Drug User Fee Act (PDUFA) action date for the Fampridine-SR NDA is October 22, 2009.
In briefing documents released today, the FDA said an efficacy trial of Amaya indicated that the improvement in walking speed was" of questionable clinical significance," although the agency added that the drug did meet its primary endpoint overall. The agency added that the improvement in lower body muscles created by the drug is "clinically difficult to interpret."
The FDA also noted that patients who received Amaya did not believe that their walking improved significantly more than those who received a placebo.
The Advisory Committee meeting is scheduled for 8:00 a.m. ET on Wednesday, October 14th. The briefing materials can be accessed at: