UCB : FDA Approves Fintepla Oral Solution To Treat Seizures Associated With Lennox-Gastaut Syndrome

(RTTNews) - UCB said that the U.S. Food and Drug Administration has approved Fintepla (fenfluramine) oral solution CIV for the treatment of seizures associated with Lennox-Gastaut syndrome in patients two years of age and older. It is already approved for the treatment of seizures associated with Dravet syndrome in patients two years of age and older.

Fintepla was developed by Zogenix Inc., which was recently acquired by UCB.

Lennox-Gastaut Syndrome is a severe childhood-onset developmental and epileptic encephalopathy characterized by drug-resistant seizures with high morbidity4 as well as serious impairment of neurodevelopmental, cognitive, and motor functions.

FINTEPLA (fenfluramine) oral solution is a prescription medication approved by the FDA and EMA, and under regulatory review with PMDA (Japan), for the treatment of seizures associated with Dravet syndrome in patients two years of age and older. A Type II Variation Application for treatment of seizures associated with LGS has also been submitted to the European Medicines Agency (EMA).

In the United States, FINTEPLA is available only through a restricted distribution program called the FINTEPLA REMS program. FINTEPLA is available in Europe under a controlled access program requested by the EMA to prevent off-label use for weight management and to confirm that prescribing physicians have been informed of the need for periodic cardiac monitoring in patients taking FINTEPLA.