Zogenix bags Fintepla FDA approval for Dravet syndrome treatment
Fintepla FDA approval : Zogenix has bagged approval from the US Food and Drug Administration (FDA) for Fintepla (fenfluramine) oral solution, CIV for the treatment of seizures associated with Dravet syndrome in patients aged two years of age and older.
Considered to be a life-threatening, rare and chronic type of epilepsy, Dravet syndrome is usually characterized by severe and unrelenting seizures in spite of medical treatment.
Commenting on Fintepla FDA approval, Billy Dunn – director of the Office of Neuroscience in the FDA Center for Drug Evaluation and Research, said: “Dravet syndrome is a debilitating disease that takes a tremendous toll on both patients and their families.
“Fintepla offers an additional effective treatment option for the treatment of seizures associated with Dravet syndrome. The FDA will continue to work with companies on drug development for Dravet syndrome and other types of epilepsy.”
Fintepla plans to commercially launch the newly approved Dravet syndrome treatment in July.
Fintepla FDA approval in Dravet syndrome was driven by the data from a couple of randomized, double-blinded, placebo-controlled phase 3 clinical trials alongside safety data from an open-label extension trial in which several patients were given the drug for up to three years.
According to Zogenix, Fintepla when added to existing treatment regimens, significantly brought down the monthly convulsive seizure frequency compared to placebo in patients whose seizures were not controlled adequately on one or more antiepileptic drugs. Additionally, most of the patients responded to treatment with the drug within three to four weeks and effects remained consistent over the treatment period, said the US-based pharma company.
Stephen J. Farr – President and CEO of Zogenix, commenting on Fintepla FDA approval, said: “The approval of FINTEPLA by the FDA is a significant milestone we are proud to celebrate with the patients and families living with Dravet syndrome.
“We began this global development program nearly six years ago after researchers in Belgium recognized the potential of fenfluramine, a drug with distinct pharmacology from all other anticonvulsant agents, to treat intractable seizures in Dravet syndrome. Our heartfelt gratitude goes to the patients, families, and everyone who supported the rigorous development program that led to FINTEPLA’s approval.”
Fintepla was previously granted priority review and orphan drug designation by the FDA in Dravet syndrome.