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FDA pushes back decision on Zogenix epilepsy drug

February 27, 2020

The success of Fintepla is crucial for Zogenix, which has only one other drug in clinical trials, MT1621, for a rare genetic disorder called thymidine kinase 2 deficiency. Analysts at Stifel forecast potential U.S. sales of more than $400 million for Fintepla in Dravet syndrome, with added potential for use in another severe form of epilepsy known as Lennox-Gastaut syndrome.

While the company didn’t give any details on the new information that triggered the delay, Stifel analysts said they heard from management that the request was about an efficacy analysis and wasn’t about safety or an analysis of whether the Phase 3 trials were successful.

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