UCB reports positive results from Phase 3 study of fenfluramine in CDKL5

UCB (UCBJF) announced that the Phase 3 study investigating the safety and efficacy of adjunctive fenfluramine in CDKL5 deficiency disorder met its primary and most key secondary endpoints. The study is a randomized, double-blind, placebo-controlled, fixed-dose, multi-center study examining the efficacy and safety of adjunctive fenfluramine treatment in 87 individuals aged one through 35, with a CDD diagnosis and uncontrolled seizures. In the study, fenfluramine was generally well tolerated, and the safety profile was consistent with previous studies in DS/LGS.3 UCB is currently conducting an open-label, flexible-dose, long-term 54-week extension phase of the study to characterize the long-term safety and tolerability of fenfluramine in pediatric and adult individuals with CDD.