UCB’s Fintepla (fenfluramine) Receives the US FDA’s Approval for the Treatment of Seizures Associated with Lennox-Gastaut Syndrome
- The approval was based on the P-III trial evaluating Fintepla (0.7/mg/kg/day) vs PBO in 263 patients aged 2-35yrs. with seizures associated with LGS
- The results showed a reduction in the frequency of drop seizures, fourth of those patients on fenfluramine experienced a ≥50% reduction in drop seizure frequency/28 days, 18% with >50 to <75% reduction & 6% with >75% reduction & improvements on CG-I
- The company provides the patient support program, Zogenix Central that enables the patients to access Fintepla including assistance with product access & ongoing support to patients, caregivers & medical teams. The product is available in the US through the FINTEPLA REMS program
Ref: UCB | Image: UCB
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