FDA approves new therapy for Dravet syndrome

The US Food and Drug Administration yesterday approved Fintepla (fenfluramine), a Schedule IV controlled substance, for the treatment of seizures associated with Dravet syndrome in patients aged two and older. Dravet syndrome is a life-threatening, rare and chronic form of epilepsy. It is often characterized by severe and unrelenting seizures despite medical treatment.

The drug’s developer, USA-based CNS-focused biotech Zogenix (Nasdaq: ZGNX), whose shares leapt 16.75% to $32.71 in pre-market trading this morning, said that Fintepla will be launched through a restricted distribution program, called the Fintepla Risk Evaluation and Mitigation Strategy (REMS) Program, and is expected to be available through Zogenix' specialty pharmacy partner by the end of July.

The FDA initially refused the New Drug Application (NDA) for Fintepla, citing several critical issues, including the failure to include non-clinical studies that addressed chronic administration of Fintepla’s active compound.