欧洲药品管理局人用医药产品委员会建议批准cenobamate辅助治疗成人局灶性发作性癫痫

On January 29, 2021, Arvelle Therapeutics, an emerging biopharmaceutical company focused on bringing innovative treatments to patients with central nervous system (CNS) diseases, announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended approval of cenobamate as an adjuvant treatment for adult patients with focal seizures with or without secondary generalization who are not adequately controlled despite a history of treatment with at least 2 antiepileptic products.

There are an estimated 6 million people with epilepsy in Europe, and approximately 40% of adult patients with epilepsy have inadequate seizure control after treatment with two antiepileptic drugs (ASMs).

Mark Altmeyer, President and CEO of Arvelle Therapeutics, said: "Despite the large number of ASMs available today, a significant proportion of patients still experience seizures, which can have a devastating impact on their lives and the lives of their families. Cenobamate has been shown to significantly improve epilepsy control of focal seizures in adult patients, and this positive opinion from the CHMP means patients may soon have a new treatment option."

"This drug has been 20 years in the making, and once approved, SK Biopharma will work with its European partners to ensure its introduction to the epilepsy community," said Dr. Jeong Woo Cho, CEO of SK Biopharmaceuticals.

The CHMP's positive opinion is based on three trials involving more than 1,900 patients. Among them, Trial 017 is a multi-center, double-blind, randomized, placebo-controlled trial, which shows that cenobamate is an effective treatment option for adult patients with focal seizures taking 1-3 ASMs.

Cenobamate demonstrated higher response rates (percentage of patients achieving a greater than 50% reduction in seizure frequency) at all doses compared with placebo during the 12-week maintenance phase. Patients who achieved a greater than 50% reduction in seizure frequency experienced remission rates of 40%, 56%, and 64% in the three dose groups of cenobamate (100 mg/day, 200 mg/day, and 400 mg/day), respectively, compared with 25% for placebo.

Additionally, during the maintenance phase, 4%, 11%, and 21% of patients treated with cenobamate 100 mg, 200 mg, and 400 mg, respectively, reported a 100% reduction in seizure frequency (100% seizure-free), compared with only 1% of placebo-treated patients.

Reference: ONTOZRY™ (cenobamate) receives positive CHMP opinion for the adjunctive treatment of uncontrolled focal onset seizures in adults