Posted by Michael Wonder on 04 Jan 2022
Zogenix submits type II variation application to the EMA to expand the use of Fintepla (fenfluramine) for the treatment of seizures associated with Lennox-Gastaut syndrome
20 December 2021 - Zogenix today announced that it has submitted its type II variation market authorisation application to the EMA for Fintepla for the treatment of seizures associated with Lennox-Gastaut syndrome, a highly treatment-resistant form of childhood-onset epilepsy.
The EMA submission for Fintepla is supported by data from a global randomised, placebo controlled Phase 3 clinical trial (Study 1601) in 263 patients (age 2-35 years) that demonstrated Fintepla at a dose of 0.7/mg/kg/day was superior to placebo in reducing the frequency of drop seizures (p=0.0012).
