FDA approves Fintepla oral solution for treatment of seizures associated with Lennox-Gastaut syndrome.
UCB announced that Fintpla(fenfluramine) oral solution CIV has been approved in the United States, by the FDA for the treatment of seizures associated with Lennox-Gastaut syndrome in patients two years of age and older.
Additionally, the FDA has granted pediatric exclusivity for the product. It is already approved for the treatment of seizures associated with Dravet syndrome in patients two years of age and older in the US and EU.Fenfluramine for LGS is available in the US through a restricted distribution program, called the Risk Evaluation and Mitigation Strategy (REMS) Program.
LGS is a severe childhood-onset developmental and epileptic encephalopathy (DEE) characterized by drug-refractory seizures with high morbidity as well as serious impairment of neurodevelopmental, cognitive, and motor functions. LGS affects an estimated 30,000 – 50,000 patients in the U.S. LGS has far-reaching effects beyond seizures, including issues with communication, psychiatric symptoms, sleep, behavioral challenges, and mobility. Additionally, sudden unexpected death in epilepsy (SUDEP) is a major concern for people living with LGS.
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