Acorda Therapeutics, Inc. (ACOR) announced that U.S. Food and Drug Administration Peripheral and Central Nervous System Drugs Advisory Committee voted 12 yes to 1 no for the clinical data of Fampridine-SR 10 mg twice daily that it demonstrated substantial evidence of effectiveness as a treatment to improve walking in people with multiple sclerosis.
The panel also voted 10 yes to 2 no for clinical significance and can be safe for use.
The Committee also recommended by a vote of 12 to 1 that Acorda be required to evaluate the effects of doses lower than 10 mg twice daily, but by a 10 to 2 vote that these studies not be required prior to approval.
At the request of the FDA, the Committee discussed possible conditions for use, including for patients with renal impairment or history of seizure. Acorda has proposed a Risk Evaluation and Mitigation Strategy program, which could include healthcare professional and patient education around appropriate use of Fampridine-SR.
The FDA seeks the advice of an advisory committee such as the PCNSD when evaluating a potential new treatment, but is not required to follow its recommendation. The current Fampridine-SR Prescription Drug User Fee Act date set by the FDA is October 22, 2009; the PDUFA date is the target date for the FDA to complete its review of Fampridine-SR.
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