FDA authorises SK Biopharmaceuticals' anti-epileptic drug Xcopri

The FDA said that it approved SK Biopharmaceuticals' Xcopri (cenobamate) to treat partial-onset seizures in adults, with the anti-epileptic drug expected to be available in the second quarter of 2020 following scheduling by the US Drug Enforcement Administration. Billy Dunn, director of the Office of Neuroscience in the FDA's Center for Drug Evaluation and Research, remarked "patients can have different responses to the various seizure medicines that are available. This approval provides an additional needed treatment option for people with this condition."

According to the agency, approval was based on results from Study 013 and Study 017 involving a combined 655 adults, with data showing that once-daily Xcopri, also known as YKP3089, reduced the percent of seizures per 28 days compared with placebo. Meanwhile, SK Biopharmaceuticals said that during the maintenance phase of Study 013, a post-hoc analysis indicated that 28% of patients receiving Xcopri had zero seizures, versus 9% for placebo.

The FDA noted that drug reaction with eosinophilia and systemic symptoms (DRESS), also known as multiorgan hypersensitivity, has been reported among patients taking Xcopri, while one person died in a clinical study after the drug was titrated rapidly. The regulator added that a higher percentage of patients who took Xcopri had a shortening of the QT interval of greater than 20 milliseconds compared to placebo.

SK Biopharmaceuticals said that the approval of Xcopri "marks the first time a Korean company has independently brought a compound from discovery" to FDA approval. Earlier this year, the company entered a licensing agreement with Arvelle Therapeutics to develop and commercialise the therapy in Europe.

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