Application for Fintepla in Dravet Syndrome rejected by FDA

The FDA has refused to fully review the marketing application for Fintepla (low-dose fenfluramine) from Zogenix, developed to treat seizures caused by Dravet syndrome. The submission was based on data from two pivotal Phase III trials and an open-label extension study, which demonstrated highly significant, safe and durable seizure reduction. The trials showed that children and young adults treated with the drug achieved a 54% greater reduction in mean monthly convulsive seizures, paired with a median longest seizure-free interval of 22 days, as opposed to 13 days for patients in the placebo group.

Zogenix did not submit certain non-clinical studies which would have allowed the FDA to assess chronic administration of the drug. In addition, the company submitted the wrong version of a clinical dataset, so preventing the FDA from completing the review.