FDA Panel Backs Acorda Therapeutics Treatment
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ACOR
WASHINGTON (AP) — Federal health officials said Wednesday that Acorda Therapeutics Inc.'s experimental multiple sclerosis drug appears safe and effective.
A panel of Food and Drug Administration experts voted in favor of the company's Fampridine-SR as a treatment to improve patients' ability to walk. The agency is not required to follow the group's advice, though it usually does. Multiple sclerosis affects the brain and nervous system, causing loss of balance, muscle spasms and other movement problems. Hawthorne, N.Y.-based Acorda conducted two trials tracking patients ability to complete a walking exercise. While both studies showed significant improvement in patients' walking ability, the actual time to complete the exercise did not improve. FDA is scheduled to make a decision on the drug by Oct. 22. Government scientists noted an increased risk of seizures with the drug at 20 milligrams, or double the 10 milligram recommended dose. The panel of experts said the company should be required to study lower doses of the drug, but that those studies could be conducted after it drug is approved.- Loading Comments...
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