FDA refuses Zogenix seizure drug

April 9, 2019

The U.S. Food and Drug Administration refused to fully review the Zogenix marketing application for its treatment for seizures associated with Dravet syndrome, a rare form of childhood epilepsy.

The drug is planned to be branded as Fintepla and uses a low-dose, liquid solution of fenfluramine. The solution was previously used in an obesity drug combination that was pulled due to evidence of heart valve damage.

The FDA, after a preliminary review, cited a lack of certain non-clinical studies to assess the chronic administration of fenfluramine and due to an incorrect dataset.

Read the Reuters report.