Acorda submits Fampridine-SR NDA

9 February 2009

The USA's Acorda Therapeutics has submitted a New Drug Application to the Food and Drug Administration for Fampridine-SR (4-aminopyridine), a  novel therapy designed to improve walking ability in people with  multiple sclerosis.

The company expects that the NDA filing, if accepted, will be subject to  standard review, which would provide a 10-month target for the FDA to  complete its approval from receipt of the submission.

Approximately 400,000-500,000 people in the USA have MS, and recent  studies indicate that between 64-85% of people with the condition have  walking disability. 70% of people with MS who have thi symptom report it  to be the most challenging aspect of their disease.

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