Zogenix Reports the US FDA Acceptance of NDA and Granted Priority Review for Fintepla (fenfluramine) to Treat Dravet Syndrome

Zogenix Reports the US FDA Acceptance of NDA and Granted Priority Review for Fintepla (fenfluramine) to Treat Dravet Syndrome

Shots:

  • The NDA is based on two P-III studies and an interim analysis from an ongoing OLE study which includes assessing Zogenix in 232 patients with Dravet syndrome for up to 21mos.
  • The two P-III study resulted in meeting 1EPs and all 2EPs. Additionally, Zogenix is also investigating Fintepla in Lennox-Gastaut syndrome in P-III study with its anticipated resulted in Q1’20
  • Fintepla (ZX008, oral solution) is a therapy being developed for the treatment of seizures associated with Dravet syndrome with its PDUFA date as March 25, 2020

Click here to­ read full press release/ article | Ref: Zogenix  | Image: LinkedIn