FDA approve oral solution for rare childhood epilepsy
pharmafile | March 28, 2022 | News story | Sales and Marketing |
UCB has announced that FINTEPLA® (fenfluramine) oral solution CIV has been approved by the FDA for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients two years of age and older. LGS affects an estimated 30,000 – 50,000 patients in the US.
The FDA has also granted paediatric exclusivity for the product, which is already approved for the treatment seizures associated with Dravet syndrome in patients two years of age and older in the US and EU.
“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,” said Mike Davis, Head of Global Epilepsy, UCB. “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.”
Fenfluramine for LGS is available in the US through a restricted distribution program, called the Risk Evaluation and Mitigation Strategy (REMS) Program.
Lennox-Gastaut syndrome (LGS) is a severe form of childhood epilepsy with multiple types of seizures. LGS is a developmental and epileptic encephalopathy (DEE) and is characterised by drug-refractory seizures, with high morbidity. In one out of four people, no cause can be found, and LGS usually persists through childhood and adolescence to adult years.
LGS causes serious impairment of neurodevelopmental, cognitive, and motor functions and has far-reaching effects beyond seizures, including issues with communication, psychiatric symptoms, sleep, behavioural changes, and mobility. Sudden unexpected death in epilepsy (SUDEP) is also a major concern for people living with LGS.
“LGS is one of the most challenging epileptic encephalopathies to treat, and the vast majority of patients are not well controlled, despite a regimen of multiple antiepileptic drugs,” said Kelly Knupp, MD, MSCS, FAES, Associate Professor, Children’s Hospital Colorado, USA. “As a complementary therapy, fenfluramine offers a different mechanism of action and demonstrated ability to significantly reduce the number of seizures associated with a drop, a critical measure for managing this severe form of epilepsy.”
Ana Ovey
