UCB’s Fintepla (fenfluramine) Receives the CHMP Recommendation for Marketing Authorization to Treat Seizures Associated with Lennox-Gastaut syndrome
- The EMA’s CHMP positive opinion was based on the safety & efficacy data from the P-III trial in 263 patients aged 2-35yrs. The EC’s final decision is expected in Q1’23
- The results showed a greater reduction in the frequency of drop seizures at a dose of 0.7/mg/kg/day & additional results of fenfluramine in the OLE part of the study showed a sustained reduction in the frequency of multiple seizure types and was well tolerated at a median treatment duration of 364 days with no cases of valvular heart disease or pulmonary arterial hypertension
- Fenfluramine was approved in the US for seizures associated with Lennox- Gastaut syndrome & in the EU, US, and Japan for seizures associated with Dravet syndrome
Ref: PRNewswire | Image: UCB
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