EMA recommends Arvelle’s seizure drug cenobamate
pharmafile | February 2, 2021 | News story | Manufacturing and Production |Â Â Arvelle Therapeutics, epilepsyÂ
The EMA has recommended the approval of Arvelle Therapeutics’ cenobamate for the adjunctive treatment of focal onset seizures with or without secondary generalisation in adult patients with epilepsy, which have not been adequately controlled despite a history of treatment with at least two anti-seizure products.
There are an estimated six million people living with epilepsy in Europe, and approximately 40% of adult people with the condition have inadequate control of seizures after treatment with two anti-seizure medications (ASMs).
The CHMP’s positive opinion was based on three trials involving over 1,900 patients. The main trial was a multicentre, double-blind, randomised, placebo-controlled trial that demonstrated that cenobamate is an effective treatment option for adult patients with focal-onset seizures taking one to three ASMs.
Cenobamate demonstrated significantly higher responder rates (percentage of patients achieving ≥50% reduction in seizures frequency) across all doses during the 12-week maintenance phase compared to placebo. The ≥50% responder rates were 40%, 56%, and 64%, for the 100mg, 200mg, and 400mg per day cenobamate groups, respectively, compared with 26% for placebo.
In addition to these findings, 4%, 11%, and 21% of patients in the cenobamate groups reported 100% reduction in seizure frequency, compared with only 1% of placebo-treated patients during the maintenance phase.
Cenobamate, which was discovered by SK Biopharmaceuticals, is already approved for the treatment of partial-onset seizures in adults in the US, where it is commercially available under the trademark XCOPRI (cenobamate tablets) CV.
Stuart Mulheron, General Manager UK & Ireland at Arvelle Therapeutics, said: “Despite the number of ASMs that are currently available, a large proportion of patients continue to have seizures which can have devastating effects on them and their families’ lives.
“Cenobamate has been shown to significantly improve seizure control for focal-onset seizures in adult patients and this positive CHMP opinion means that patients may soon have a new treatment option.”
The European Commission (EC) is expected to issue its decision within 67 days of receipt of the CHMP’s opinion. Additionally, a submission based on the same application to the EMA has been filed with the MHRA, who is expected to announce its decision shortly after the EC.
Darcy Jimenez
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