UCB’s Fintepla (fenfluramine) Receive EU Approval for Adjunctive Treatment of Seizures Associated with Lennox-Gastaut Syndrome
- Fintepla has been approved in the EU for seizures associated with LGS as an add-on therapy to other anti-epileptic medicines in patients aged ≥2yrs.
- The approval was based on safety & efficacy data from a P-III clinical trial evaluating Fintepla vs PBO in 263 patients which showed a greater reduction in the frequency of drop seizures at a dose of 0.7mg/kg/day while no cases of valvular heart disease or pulmonary arterial hypertension were reported
- Fenfluramine is a serotonin-releasing agent that stimulates multiple 5-HT receptor sub-types through the release of serotonin. To ensure consistent cardiac monitoring & to reduce potential off-label use, fenfluramine oral solution is available through a controlled access program
Ref: UCB | Image: UCB
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