Positive opinion on sebetralstat from key regulatory committee in European Union

A new medicine for HAE, called Ekterly (sebetralstat), has received a positive opinion from the European Union regulatory authorities, opening the way for it to receive a license in the EU later in 2025.

This positive opinion, from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), recommends that sebetralstat receive marketing authorization. A final decision on this will be made by the European Commission by early October 2025.

Ben Palleiko, CEO of KalVista, said: “This positive CHMP opinion is an important step forward for people living with HAE in Europe, where there remains a high need for effective, easy-to-administer on-demand treatments. Sebetralstat is expected to become the first and only oral on-demand treatment for HAE available in Europe, bringing forward a new treatment approach that enables adherence to guidelines and empowers people to treat attacks quickly, wherever they occur.”

Dr Emel Aygören-Pürsün MD, Assistant Professor, Internal Medicine and Hemostaseology, Department for Children and Adolescents, University Hospital Frankfurt, said: “Access to on-demand treatments that offer easy self-administration and rapid symptom relief is critical for patients living with HAE. Until now, on-demand therapies for HAE attacks required parenteral administration via injections. The positive CHMP opinion for sebetralstat is an essential move toward a novel, long-awaited oral on-demand option that could help patients treat attacks early and independently, as advocated by guidelines, with the goal of improving outcomes and normalizing lives.”

(Source: KalVista)