FDA Weighs Benefits, Risks Of Novartis MS drug

From Associated Press (June 8, 2010)

WASHINGTON -- Federal health regulators say a highly anticipated Novartis drug for multiple sclerosis appears effective but carries a number of side effects, including lung and eye problems.

Swiss drug maker Novartis has asked the Food and Drug Administration to approve its drug Gilenia to treat patients with relapsed multiple sclerosis, which causes tremors and movement problems. The drug is a daily pill and would offer an alternative to older injectable drugs.

FDA reviewers said two studies of the drug "provide substantial evidence for an effect."

However, FDA staff also noted a number of side effects with the drug, including eye, lung and heart problems.

On Thursday the FDA will ask a panel of experts whether the drug should be approved.

 

Posted: June 2010


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