Zogenix’s Fintepla (fenfluramine) Receives the US FDA’s Approval for the Treatment of Seizures Associated with Dravet Syndrome

Zogenix’s Fintepla (fenfluramine) Receives the US FDA’s Approval for the Treatment of Seizures Associated with Dravet Syndrome

Shots:

  • The US FDA’s approval is based on two P-III studies assessing Fintepla vs PBO in patients aged ≥2yrs. with Dravet syndrome and a safety data from an OLE trial in which many patients received Fintepla for up to 3yrs.
  • In addition to the existing treatment regimens, the therapy demonstrated a reduction in the frequency of monthly convulsive seizure in patients whose seizures were not controlled on one or more antiepileptic drugs
  • The company will launch the therapy through restricted distribution program, called the Fintepla REMS Program, and is expected to be available through Zogenix’s specialty pharmacy partner by July’20

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