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BMY - Zogenix Fintepla Approval And Other News: The Good Bad And Ugly Of Biopharma
Bristol-Myers Squibb Company
Zogenix Buoyant on FDA Approval for Fintepla
Zogenix (ZGNX) reported that the FDA has approved its Fintepla drug for treating seizures associated with Dravet syndrome. The drug may now be used for treating patients 2 years of age and older. It will be distributed under the FINTEPLA Risk Evaluation and Mitigation Strategy (REMS) Program, a restricted distribution system. The company expects the drug candidate to be available in the market by the end of July.
The FDA based its approval on the data collected from two randomized, double-blinded, placebo-controlled Phase 3 clinical trials.