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