Novo Seeks US FDA, EU Approval for Sickle Cell Disease Drug Etavopivat

06:30 AM EST, 11/13/2026 (MT Newswires) -- Novo Nordisk (NOVO-B.CO) filed applications with the US Food and Drug Administration and the European Medicines Agency for marketing approval of its sickle cell disease drug etavopivat. The Danish pharmaceutical company's FDA new drug and EMA marketing authorization submissions are based on data from a phase 3 Hibiscus trial showing the investigational therapy's efficacy and safety in adolescents and adults with the disease, according to a Friday release. The regulators, which previously granted orphan drug designations for etavopivat, are expected to take action on the applications in 2027.