FDA Puts New MS Drug on Fast Track to Approval
The Food and Drug Administration has granted priority status to an experimental multiple sclerosis (MS) drug made by Acorda Therapeutics Inc.
The drug, Fampridine-SR, would become the first MS drug to reverse a common symptom of the disease, difficulty walking.
The FDA grants priority review to proposed drugs that are considered more advanced than existing treatments in order to speed up the process of getting the drugs into the hands of physicians and patients who might benefit from their use.
Drugs on the fast track to FDA approval typically are approved within six months instead of the standard review period of 10 months. The FDA recently rejected Acorda’s new-drug application for Fampridine-SR, but the agency agreed to reconsider the application and granted priority status after just two weeks, faster than many analysts expected.
An FDA ruling on whether to approve Fampridine-SR is expected as early as Fall 2009, officials said.
Nearly Half-Million Americans Have MS
MS is a progressive disease that affects as many as 400,000 Americans. The disease causes the immune system to interfere with communication between the brain and the rest of the body by attacking nerve fibers in the brain and spinal cord.
Most people with MS report difficulties walking or with other motor problems, symptoms which Fampridine-SR is specifically designed to address.
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