UCBJF - UCB's Fintepla gets FDA approval to treat rare childhood epilepsy

The U.S. Food and Drug Administration approved UCB's (OTCPK:UCBJF) (OTCPK:UCBJY) Fintepla (fenfluramine) oral solution CIV to treat seizures associated with Lennox-Gastaut syndrome (LGS) in patients two years of age and older. The FDA has also granted Fintepla pediatric exclusivity. The drug is already approved to treat seizures associated with Dravet syndrome in patients two years of age and older. LGS is a rare and severe form of epilepsy that usually becomes apparent during early childhood. The disorder is characterized by seizures and impairment of cognitive and motor functions. The company said LGS is affects an estimated 30K – 50K patients in the U.S. The approval was based on positive data from a phase 3 trial. The company said Fintepla for LGS is available through a restricted distribution program. UCB inherited Fintepla through the acquisition of Zogenix.

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UCB's Fintepla gets FDA approval to treat rare childhood epilepsy