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