European Medicines Agency Accepts Arvelle Therapeutics’ Marketing Authorization Application for Cenobamate for the Adjunctive Treatment of Focal-Onset Seizures in Adults

The MAA is based on data from a global clinical trial program conducted by SK life science, a subsidiary of SK Biopharmaceuticals
 

SK Biopharmaceuticals Co., Ltd. announced the European Medicines Agency (EMA) acceptance of Arvelle Therapeutics’ Marketing Authorization Application (MAA) for cenobamate, an anti-epileptic drug (AED) for the adjunctive treatment of focal-onset (partial-onset) seizures in adults. In 2019, SK Biopharmaceuticals entered into an exclusive licensing agreement with Arvelle Therapeutics to develop and commercialize cenobamate in Europe. Acceptance of the MAA confirms that the submission is complete and begins the formal review process by the EMA’s Committee for Human Medicinal Products (CHMP).

The MAA is based on results from a global clinical trial program conducted by SK life science, the U.S. subsidiary of SK Biopharmaceuticals. The clinical trial program includes two global, randomized, double-blind, placebo-controlled studies and a large, global, multi-center, open-label safety study. These three studies enrolled more than 1,900 adults with uncontrolled focal-onset seizures.

“The EMA’s acceptance of the filing for cenobamate is an important step toward making a new AED available to patients in Europe,” said Jeong Woo Cho, PhD, President and CEO of SK Biopharmaceuticals and SK life science. “We congratulate the Arvelle Therapeutics team for their efforts in preparing the MAA and advancing this important potential treatment option.”

There are about 6 million people in Europe with epilepsy and approximately 40 percent of adults with focal-onset seizures continue to experience seizures, even after treatment with two AEDs, underscoring the need for new treatment options.