Positive Vote by FDA’s Advisory Committee for Fampridine-SR- Says Acorda Therapeutics
Acorda Therapeutics

Acorda Therapeutics announced that the U. S. Food and Drug Administration Peripheral and Central Nervous System Drugs Advisory Committee voted hugely in favor of the clinical data on Fampridine-SR 10 mg twice daily demonstrated significant evidence of effectiveness as a treatment to improve walking, in people with multiple sclerosis and again voted in favor of its clinical safety.

Ron Cohen, M. D., Acorda Therapeutics President and CEO said, "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".

He also said that the advisory committee was very important in the development of Fampridine-SR and that they look forward to working in collaboration with the FDA as it completes its review of Acorda’s New Drug Application.

The committee conducted another voting and the results were 12 to 1 requiring Acorda to evaluate the effects of doses lower than 10 mg two times a day.

The company also evaluated the 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.

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