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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