Brussels (Belgium), and Atlanta, Ga. - UCB (Euronext: UCB), a global biopharmaceutical company, announced that FINTEPLA (fenfluramine) oral solution CIV has been approved by the U.S. Food and Drug Administration (FDA) 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 (DS) in patients two years of age and older.1 Additionally, the FDA granted FINTEPLA pediatric exclusivity. FINTEPLA for LGS is available through a restricted distribution program, called the FINTEPLA Risk Evaluation and Mitigation Strategy (REMS) Program. FINTEPLA was developed by Zogenix, Inc., which was recently acquired by UCB.

LGS is a severe childhood-onset developmental and epileptic encephalopathy (DEE) characterized by drug-refractory seizures with high morbidity4 as well as serious impairment of neurodevelopmental, cognitive, and motor functions.5 LGS affects an estimated 30,000 - 50,000 patients in the U.S.6 LGS has far-reaching effects beyond seizures, including issues with communication, psychiatric symptoms, sleep, behavioral challenges, and mobility.[7] Additionally, sudden unexpected death in epilepsy (SUDEP) is a major concern for people living with LGS.[8]

FINTEPLA has demonstrated efficacy in the most difficult to treat seizure types,1,2 including drop seizures, which cause a person to suddenly lose muscle tone, become limp, and fall to the ground, with a high likelihood of injury.3 FINTEPLA has a mechanism of action different from and complementary to current seizure medications, and it can be used with no disruptions to current antiseizure regimens.9 In the global placebo-controlled Phase 3 clinical study, there were numerically greater improvements on the Clinical Global Impressions scale (CG-I) in patients living with LGS when taking FINTEPLA.1

'The approval of FINTEPLA for Lennox-Gastaut syndrome highlights our continued commitment to bringing differentiated medicines to patients who may not be well controlled on current therapies, and their caregivers,' said Mike Davis, Head of Global Epilepsy, UCB, Inc. 'We are proud to add FINTEPLA as a treatment for Dravet syndrome, and now Lennox-Gastaut syndrome, to our portfolio of epilepsy medicines to help reduce the impact and burden of seizures, including severe epilepsy syndromes that have high pediatric morbidity and mortality rates.'

The FDA approval was supported by safety and efficacy data from a global, randomized, placebo-controlled Phase 3 clinical trial in 263 patients with LGS (age 2-35 years), which demonstrated that FINTEPLA at a dose of 0.7 mg/kg/day significantly reduced monthly drop seizures frequency by a median of 23.7% from baseline compared to 8.7% placebo (p=0.0037). Nearly a fourth of those patients on FINTEPLA 0.7 mg/kg/day experienced a ?50% reduction in drop seizure frequency per 28 days; 18% with ?50% to

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