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Thursday

 

New Multiple Sclerosis Drug , Gilenya (Fingolimod), Expected to be Approved by FDA

(Posted By: Josi Creek)

The panel that recommends drug approvals to the FDA has unanimously agreed that the multiple sclerosis drug, fingolimod is safe and effective. The panel is comprised of 25 medical experts not employed by the FDA. The proposed drug is manufactured by the Swiss company Novartis and would be marketed under the name Gilenya. If approved, the drug is expected to bring in more than one billion dollar in annual sales for the company.




The panel recommends 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. Novartis explains 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 patients 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 Gilenya 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 typically follows the recommendations of the advisory board. They are expected to make a final approval decision by September.



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