SK Biopharm Initiates European Approval Review for Epilepsy New Drug 'Cenobamate'
US Q2 Launch Scheduled
[Asia Economy Reporter Cho Hyun-ui] The European Medicines Agency (EMA) has initiated the approval review for SK Biopharm's epilepsy drug 'Cenobamate.'
On the 27th, SK Biopharm announced that the new drug marketing authorization application submitted to the EMA by its European partner, Arvelle Therapeutics, has passed the document requirements.
Cenobamate is an epilepsy drug independently developed by SK Biopharm and received marketing approval from the U.S. Food and Drug Administration (FDA) in November last year. It is scheduled to be launched in the U.S. under the name 'Xcopri' in the second quarter of this year.
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Jungwoo Cho, CEO of SK Biopharm, stated, "Following the U.S., Cenobamate's entry into the European market is now underway," adding, "We will strive to establish it as a new treatment option for epilepsy patients worldwide."
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