On 26-Mar-2020, 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.”
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Background of agreement:
“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).”
Mechanism of action:
“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.”
Clinical trial:
“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.”
“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”
https://www.skbp.com/eng/news/view.do?boardCode=BDCD0002&boardSeq=486¤tPage=1&search=
