The Medicines and Healthcare products Regulatory Agency (MHRA) has granted Arvelle Therapeutics’ Ontozry a marketing authorisation (MA) for the adjunctive treatment of focal-onset seizures, with or without secondary generalisation.
The MA covers Ontozry (cenobamate) for use in adult patients with epilepsy who have not been adequately controlled despite treatment with at least two anti-epileptic medicinal products.
The authorisation is supported by data from clinical trials CO17 and CO21 of Ontozry, involving 1,784 patients, which showed a reduction in focal-onset seizures with Ontozry treatment.
The median percentage changes in seizure frequency were -35.5% for the 100mg doses, -55% for the 200mg dose group and -55% for the 400mg dose group versus placebo.
Adverse reactions reported in the CO17 study included vertigo, nervous system disorders, dizziness, fatigue, double vision and headaches.
“Evidence from key clinical trials indicate that Ontozry can reduce the occurrence of focal-onset seizures which may lead to a potential new management option for adults with epilepsy who have not been successful in managing their condition with available therapies,” commented Emmanuel Streel, director, medical affairs, Arvelle Therapeutics.
“Today’s decision by the MHRA means that an additional option to reducing the impact of adult epilepsy in Great Britain may now be possible,” he added.
Focal onset seizure is a type of epileptic seizure which begins in one side of the brain – in the UK, it is estimated that one in 100 people have epilepsy and 87 new cases are diagnosed each day.
“We are committed to facilitating access for eligible patients in Great Britain and are looking ahead to supporting the NICE and SMC appraisal processes in the coming months,” said Stuart Mulheron, general manager UK & Ireland, Arvelle Therapeutics.