Acorda Announces Positive Vote by FDA Advisory Committee for Fampridine-SR
Wed, Oct 14, 2009
* Committee Views Fampridine-SR as Safe, Effective and Clinically Meaningful for Improving Walking in People with Multiple Sclerosis * Conference Call Scheduled for Thursday, October 15 at 8:00 a.m. Eastern Time HAWTHORNE, N.Y.--(Business Wire)-- Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced the U.S. Food and Drug Administration (FDA) Peripheral and Central Nervous System Drugs (PCNSD) Advisory Committee voted 12 to 1 that clinical data on Fampridine-SR 10 mg twice daily demonstrated substantial evidence of effectiveness as a treatment to improve walking in people with multiple sclerosis (MS) and voted 10 to 2 (1 abstention) that it is clinically meaningful and can be safe for use. "We are pleased with the outcome of today`s Advisory Committee meeting. People with MS have an urgent need for therapies to improve their walking, which is essential to conducting their activities of daily life. If approved, Fampridine-SR would be the first medicine to improve walking in people with MS," said Ron Cohen, M.D., Acorda Therapeutics President and CEO. "This Advisory Committee meeting is an important milestone in the development of Fampridine-SR, and we look forward to working with the FDA as it completes its review of Acorda`s New Drug Application." 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 (1 abstention) 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 (REMS) 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 (PDUFA) 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. Conference Call Acorda will hold a conference call and audio webcast on Thursday, October 15, 2009 at 8:00 a.m. ET to discuss the outcome of the Advisory Committee meeting. To participate in the conference call, please dial 866-700-6979 (domestic) or 617-213-8836(international) and reference the access code 85689772. The presentation will be available via a live audio webcast at: http://phx.corporate-ir.net/phoenix.zhtml?p=irol-eventDetails&c=194451&eventID=2484252 A replay of the call will be available from 11:00 a.m. ET on October 15, 2009 until midnight on November 14, 2009. To access the replay, please dial 888-286-8010(domestic) or 617-801-6888 (international) and reference the access code 45457470. The archived webcast will be available for 30 days in the Investor Relations section of the Acorda website at http://www.acorda.com. About Fampridine-SR 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 and manufactured by Elan Corporation plc. View full post here: http://www.reuters.com/article/pressRelease/idUS211700+14-Oct-2009+BW20091014
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