Fintepla oral solution was originally developed by Zogenix, which was acquired by UCB in a transaction worth around $2bn earlier this month
FDA Centre for Drug Evaluation and Research. (Credit: The U.S. Food and Drug Administration/Wikipedia)
Belgium-based UCB has received the US Food and Drug Administration (FDA) approval for Fintepla (fenfluramine) oral solution CIV to treat a rare type of epilepsy in children.
The drug has been indicated for the treatment of seizures related to Lennox-Gastaut syndrome (LGS) in children, aged two years and above.
LGS is a severe developmental and epileptic encephalopathy (DEE), characterised by drug-refractory seizures, as well as serious impairment of cognitive, and motor functions.
In addition to the regulatory approval, the US agency has granted paediatric exclusivity for the therapy, said UCB.
Fintepla oral solution is a prescription medication originally developed by Zogenix, which was acquired by UCB in a transaction worth around $2bn earlier this month.
The drug was previously approved in the US, the EU, and Japan to treat Dravet syndrome-related seizures in children.
Fenfluramine is available in the US through a restricted distribution programme, known as the Risk Evaluation and Mitigation Strategy (REMS).
UCB global epilepsy head Mike Davis said: “The approval of fenfluramine 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.
“We are proud to add fenfluramine 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 paediatric morbidity and mortality rates.”
The FDA approval was based on safety and efficacy data from a global, randomised, placebo-controlled Phase 3 clinical trial in 263 patients with LGS.
In the Phase 3 trial, the drug showed significant improvements for patients living with LGS, based on the Clinical Global Impression scale (CG-I).
The treatment using fenfluramine at a dose strength of 0.7/mg/kg/day has reduced the frequency of drop seizures compared to placebo.
Drop seizures are the most difficult to treat seizure types, where people suddenly lose their muscle tone, become limp, and fall to the ground with chances of injury.
The common adverse reactions in patients treated with fenfluramine include diarrhoea, decreased appetite, fatigue, somnolence, and vomiting.
Furthermore, UCB is launching the Zogenix Central programme that will provide patients, caregivers, and their medical teams with access to fenfluramine.