FDA refuses to review Zogenix’s Fintepla in Dravet syndrome, shares tumble 30%

pharmafile | April 9, 2019 | News story | Manufacturing and Production, Sales and Marketing Dravet Syndrome, FDA, Fintepla, Zogenix 

California-based biopharma firm Zogenix has been left frustrated after it received a correspondence from the FDA noting its refusal to review the company’s Fintepla (fenfluramine hydrochloride) therapy in the treatment of seizures associated with Dravet syndrome, a rare form of childhood epilepsy.

Zogenix confirmed that it had received a “refusal to file” letter this week, citing two major issues preventing progress: lack of clinical evidence supporting the drug’s continued efficacy in chronic use, and the submission of an incorrect version of a clinical dataset. The move sent Zogenix’s shares tumbling by as much as 31%, down to just over $35 per share.

However, Zogenix noted that, despite the identification of these problems, the US regulator has not requested further clinical data or the execution of additional studies. The company confirmed it would be arranging to meet with the FDA to address the issues.

If the company can secure regulatory approval, Fintepla will go head-to-head with GW Pharma’s recently approved cannabidiol therapy Epidiolex, which secured the first FDA approval in Dravet syndrome last year.

Matt Fellows

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