Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that the U.S. Food and Drug Administration (FDA) has extended the PDUFA goal date for its review of the New Drug Application (NDA) for Fampridine-SR to January 22, 2010. The original Prescription Drug User Fee Act (PDUFA) date for this priority review application was October 22, 2009.
Following the Peripheral and Central Nervous System Drugs Advisory Committee meeting on Fampridine-SR, Acorda submitted additional information on its proposed Risk Evaluation and Mitigation Strategy (REMS) program. The FDA accepted this submission as a solicited major amendment to the Fampridine-SR NDA. The FDA has the option to 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 REMS program is important to ensuring appropriate use of Fampridine-SR, if approved, and we are pleased that the FDA has accepted our amendment,” said Ron Cohen, M.D., President and CEO of Acorda Therapeutics. “We look forward to continuing to work with the FDA as it completes its review of the Fampridine-SR NDA.”
Fampridine-SR is a sustained-release tablet formulation of the investigational drug fampridine (4-aminopyridine or 4-AP). In laboratory studies, fampridine has been found to improve impulse conduction in nerve fibers in which the insulating layer, called myelin, has been damaged. Fampridine-SR is being developed by Acorda Therapeutics in the United States and manufactured by Elan Corporation plc.
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