Policy & Regulation
Zogenix Inc awarded FDA approval for FINTEPLA oral solution for treatment of Dravet syndrome
26 June 2020 -

Pharmaceutical company Zogenix Inc (NASDAQ:ZGNX) announced on Thursday the receipt of approval from the US Food and Drug Administration (FDA) for FINTEPLA (fenfluramine) oral solution, CIV for the treatment of seizures associated with Dravet syndrome in patients two years of age and older.

Dravet syndrome is a rare childhood-onset epilepsy marked by frequent and severe treatment-resistant seizures, associated hospitalizations and medical emergencies, significant developmental and motor impairments, and an increased risk of sudden unexpected death (SUDEP).

Launched through a restricted distribution program, the FINTEPLA Risk Evaluation and Mitigation Strategy (REMS) Program, FINTEPLA is expected to be available through the company's specialty pharmacy partner by the end of July.

The FDA's approval of FINTEPLA in Dravet syndrome was based on data from two randomized, double-blinded, placebo-controlled Phase 3 clinical trials and safety data from an open-label extension trial. In the Phase 3 trials, the reduction in convulsive seizure frequency per 28 days was statistically significantly greater for all dose groups of FINTEPLA compared to placebo, Zogenix said.

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