Brazil Approves Xcopri for Drug-Resistant Focal Epilepsy as Eurofarma Secures Registration

Overview

• Anvisa authorized Xcopri (cenobamate) for adults with focal seizures who failed at least two prior treatments, with the approval published on March 9.
• Eurofarma said it received Anvisa registration to manufacture and market the drug in Brazil under a license from SK Biopharmaceuticals and expects to launch this year.
• Commercialization cannot begin until the drug’s maximum price is set by the medicines market regulator CMED.
• Potential availability in Brazil’s public health system will depend on a Conitec assessment followed by a Ministry of Health decision.
• Clinical data show dose-dependent efficacy—about 40% achieving at least 50% seizure reduction at 100 mg and 64% at 400 mg versus 26% on placebo—with use contraindicated in familial short QT syndrome.