FDA panel unanimously backs effectiveness of 1st pill-form drug for multiple sclerosis

By AP
Thursday, June 10, 2010

FDA panel says Novartis sclerosis drug works

SILVER SPRING, Md. — Federal health experts say a first-of-a-kind multiple sclerosis drug from Novartis is effective at controlling tremors, concentration problems and other symptoms of the debilitating disease.

Swiss drugmaker Novartis has asked the Food and Drug Administration to approve its drug Gilenia as the first pill for multiple sclerosis. All of the existing drugs require frequent injections or infusions.

The Food and Drug Administration’s panel of nervous system experts voted 25-0 that Gilenia helps reduce relapses of multiple sclerosis, which causes of host of movement and cognitive problems.

The panel is scheduled to vote on the drug’s safety later this afternoon. The FDA is not required to follow the group’s advice, though it usually does.

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