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ONTOZRY® (Cenobamate) receives European Commission approval
2021.03.31ONTOZRY® (Cenobamate) receives European Commission approval for the treatment of drug-resistant focal-onset seizures in adults
SK Biopharmaceuticals and Angelini Pharma will collaborate to launch the treatment in countries in the European Economic Area
Pangyo, Gyeonggi Province, Korea, March 30, 2021 – SK Biopharmaceuticals, Co., Ltd., a global innovative pharmaceutical company, announced today that cenobamate received marketing authorization from the European Commission (EC) under the brand name ONTOZRY® for the adjunctive treatment of focal-onset seizures with or without secondary generalization in adult patients who have not been adequately controlled despite a history of treatment with at least two anti-epileptic medicinal products.
The marketing authorization, granted to Arvelle Therapeutics, recently acquired by Angelini Pharma, will be valid in all European Union Member States as well as Iceland, Norway and Liechtenstein. Angelini Pharma plans to launch ONTOZRY® in the European Union and other countries in the European Economic Area (Switzerland and the United Kingdom). SK Biopharmaceuticals, which discovered and developed cenobamate, will collaborate with Angelini Pharma to launch ONTOZRY® in Europe. Cenobamate was approved by the U.S. Food and Drug Administration (FDA) for the treatment of partial-onset (focal-onset) seizures in adults in 2019 and is commercially available in the U.S. under the brand name XCOPRI® (cenobamate tablets) CV.
“The approval by the European Commission is another major milestone in our efforts to increase access to cenobamate and to support patients with a much-needed new treatment option,” said Jeong Woo Cho, PhD, President and CEO of SK Biopharmaceuticals and SK life science. “As a fully-integrated global pharmaceutical company, we are committed to discovering, developing and delivering new treatment options for epilepsy and other central nervous system disorders to people around the world.”
Epilepsy is one of the most common neurological diseases in the world, and an estimated six million people in Europe live with seizures.1 Among adult patients with focal-onset seizures, approximately 40% continue to experience seizures after treatment with two anti-seizure medications (ASMs).
The approval was 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 randomized, double-blind, placebo-controlled studies and a large, multi-center, open-label safety study. These three studies enrolled more than 1,900 adults with uncontrolled focal-onset seizures.
“ONTOZRY will be a welcome new treatment option in Europe for adults who have not yet been able to control their focal-onset seizures with available treatments. Treatment-resistant epilepsy has a devastating effect on these patients and their families, and we are proud to help address this urgent health challenge,” said Pierluigi Antonelli, CEO of Angelini Pharma. “Angelini Pharma looks forward to bringing ONTOZRY to these patients across Europe and will continue to help address the needs of patients with central nervous system disorders through our innovative product portfolio and pipeline.”
Media Inquiries
SK Biopharmaceuticals
Hyongki Park, Head of Communications
skbp_comm@sk.com
Angelini Pharma
Daniela Poggio, Executive Director Global Communications
daniela.poggio@angelinipharma.com