EMA grants marketing authorisation for Cenobamate for treating Focal Seizures in Adults

PANGYO - European Medicines Agency (EMA) has accepted 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.

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.

Cenobamate is an FDA-approved anti-epileptic drug (AED) for the treatment of partial-onset seizures in adults. In the U.S., the drug will be marketed under the brand name XCOPRI® (cenobamate tablets) CV and is expected to be available in the second quarter of 2020. It was discovered and developed by SK Biopharmaceuticals and SK life science. In 2019, SK Biopharmaceuticals entered into an exclusive licensing agreement with Arvelle Therapeutics to develop and commercialize cenobamate in Europe.

While the precise mechanism by which cenobamate exerts its therapeutic effect is unknown, cenobamate is believed to reduce repetitive neuronal firing by inhibiting voltage-gated sodium currents and as a positive allosteric modulator of the γ‑aminobutyric acid (GABAA) ion channel.

Long-term safety of cenobamate has been evaluated in the ongoing open-label extensions of the randomized studies and the open-label safety study. Additional clinical trials are investigating cenobamate in other seizure types.

More information is available at http://Arvelletx.com.