Live Breaking News & Updates on Epilepsy Alliance Europe
Stay updated with breaking news from Epilepsy alliance europe. Get real-time updates on events, politics, business, and more. Visit us for reliable news and exclusive interviews.
Share this article PANGYO, GYEONGGI PROVINCE, Korea, Jan. 29, 2021 /PRNewswire/ SK Biopharmaceuticals announced that the European Medicines Agency s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of cenobamate for the adjunctive treatment of focal-onset (partial-onset) seizures with or without secondary generalization in adult patients with epilepsy who have not been adequately controlled despite a history of treatment with at least two anti-seizure medications (ASMs). The European Commission (EC), which is authorized to approve medicines in the European Union, is expected to issue its decision within approximately 67 days of receipt of the CHMP opinion. SK Biopharmaceuticals and Arvelle Therapeutics entered into a licensing agreement in 2019 for Arvelle to commercialize SK Biopharmaceuticals cenobamate in Europe. Cenobamate has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of partial-onse ....
ONTOZRY™ (cenobamate) receives positive CHMP opinion for the adjunctive treatment of uncontrolled focal onset seizures in adults January 29, 2021 12:20 ET | Source: Arvelle Therapeutics Arvelle Therapeutics Positive CHMP opinion is an important milestone for Arvelle Therapeutics and cenobamate When approved, cenobamate will provide new hope in helping adult patients with uncontrolled focal epilepsy move closer to the goal of seizure reduction and seizure freedom ZUG, Switzerland, Jan. 29, 2021 (GLOBE NEWSWIRE) Arvelle Therapeutics, an emerging biopharmaceutical company focused on bringing innovative treatments to patients suffering from central nervous system (CNS) disorders, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of cenobamate for the ....