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Gilenia Gets Stamp of Approval From Advisory Panel to FDA

6/11/2010

The first oral medication to treat MS has moved one step closer to reality, as advisors to the Food and Drug Administration (FDA) have “generally recommended” Gilenia from Novartis as an initial treatment for MS. The recommendation passed by a 21-3 vote yesterday in Silver Spring, Maryland. The panel voted unanimously in favor of the pill’s safety and effectiveness. Though it is not required to do so, the FDA usually follows panel recommendations, and is scheduled to decide whether to approve Gilenia by September.

The panel that made the recommendation consists of 25 medical experts not employed by the FDA. It has also recommended another study be completed that involves a lower dosage amount but does not feel approval should wait on those results. The current dosage is being recommended at 0.5 milligrams. The panel voted for studies to be completed with a dosage of .25 milligrams to determine the drug’s effectiveness at a lower, safer dosage.  The new studies would take at least five to six years to complete. The FDA requires new drugs to have post approval studies completed as well. Those studies would include people who suffer from other ailments along with MS and determine if the drug side effects are more prevalent in those groups.

Some of the side effects associated with Gilenia include a low heart rate, a slight decrease in lung function, and macular edema, an eye problem. The drug is designed to delay the debilitating effects of MS. Novartis is hoping to get their drug approved before their competitor Merck reveals its own version of an MS drug. The FDA is expected to make a final approval decision by September.



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