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