FDA advisory committee supports efficacy, safety data of Acorda's MS drug
HAWTHORNE, N.Y. A Food and Drug Administration advisory committee has given favorable review to an investigational drug for multiple sclerosis.
Acorda Therapeutics announced the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted 12-to-1 to support the efficacy data and 10-to-2 to support the safety data of the drug fampridine-SR in patients taking 10 mg of the drug twice daily to improve walking ability.
“We are pleased with the outcome of [today’s] advisory committee meeting,” Acorda president and CEO Ron Cohen said in a statement. “People with MS have an urgent need for therapies to improve their walking, which is essential to conducting their activities of daily life.”
The committee’s vote does not guarantee approval of the drug, but the FDA seeks the advice of advisory committees when making its final decision on whether to grant approval.
The committee’s vote stands in contrast to comments that FDA officials made last week in documents posted on the agency’s Web site, in which they said the drug had “very limited effect” despite promising clinical trial data, causing the company’s stock to fall by 18% on NASDAQ. Trading of Acorda’s stock on NASDAQ has since stopped.
The drug maker's shares soared by $8.43 (50%) to $25.17 Thursday morning. It was the shares' biggest gain since they tripled on Sept. 25, 2006, according to reports.