- 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
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