UCB nabs TGA approval for first dual action anti-seizure therapy

UCB Australia has secured Therapeutic Goods Administration (TGA) approval for the first dual action anti seizure medicine, Fintepla (fenfluramine). The drug is indicated as an add-on therapy for managing seizures associated with Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS) in patients aged two years and older.

Professor Ingrid Scheffer AO, Chair of Paediatric Neurology Research at the University of Melbourne, emphasised the severity of Dravet syndrome, describing it as “one of the more frequent, severe forms of epilepsy [with] a high mortality risk of 17% by 20 years of age, often due to SUDEP (sudden unexpected death in epilepsy).”

She further added, “Seizure control is crucial to improve long term outcome for children and adults with Dravet syndrome and reduce the risk of SUDEP. The TGA registration of Fintepla is a major step forward in the evolution of treatment of severe epilepsies and provides hope for eligible patients with Dravet syndrome and Lennox-Gastaut syndrome.”

A recent review found that adjunctive Fintepla significantly reduced convulsive seizure frequency in Dravet Syndrome patients, with sustained effects lasting up to three years. For Lennox-Gastaut Syndrome, the therapy demonstrated a reduction in drop seizure frequency, sustained for up to one year.

Notably, the therapy was also associated with “clinically meaningful improvements in aspects of everyday executive functioning (EF) not entirely explainable by seizure reduction alone,” the authors wrote.

Selina Clifford, General Manager of UCB ANZ, stated “UCB Australia is dedicated to improving the lives of people living with rare and severe forms of epilepsy. With advancements in understanding the genetic mutations behind Dravet Syndrome and Lennox-Gastaut Syndrome, we remain focused on developing innovative solutions to address the unique challenges of these devastating diseases to give Australians access to the care and treatment they need.”

The active ingredient in Fintepla, fenfluramine, has a complex history. Previously used in the anti-obesity medication Fen-Phen, fenfluramine was withdrawn globally after being linked to pulmonary hypertension and heart valve disease. However, its new role in epilepsy treatment offers renewed hope for patients and their families facing these challenging conditions.

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