SK Biopharm's anti-epileptic drug gets EMA approvalThe European Union's drug agency has recommended the approval of an anti-epileptic drug of SK Biopharmaceuticals, paving the way for its sales in the region, the biopharmaceutical affiliate of Korea's SK Group said Monday.
The Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency recommended the application of cenobamate, SK Biopharmaceuticals said in a press release.
The European Commission, which is authorized to approve medicines in the region, is expected to issue its decision within 67 days of receipt of the CHMP opinion.
SK Biopharmaceuticals said that cenobamate is expected to hit the shelves in the region in the second quarter of this year, providing new hope in helping adult patients with uncontrolled focal epilepsy.
Cenobamate, branded as XCOPRI in the United States, earned the U.S. Food and Drug Administration's approval in 2019 to be used as a treatment for partial-onset seizures in adults.
The approval marked the first time a Korean company has applied for FDA approval for a drug on its own and received it. SK Biopharmaceuticals has been developing the anti-epileptic drug since 2001.
SK Biopharm's European partner, Italy-based drug firm Angelini Pharma, will be responsible for marketing and sales of the drug in the region under the brand name of Ontozry.
An estimated 6 million people in Europe suffer from epilepsy. People with epilepsy, whose seizures are poorly controlled, have higher morbidity and mortality rates.