Positive opinion on donidalorsen from key regulatory committee in European Union

A new medicine for HAE, called Dawnzera (donidalorsen), has received a positive opinion from the European Union regulatory authorities, opening the way for it to receive a license in the EU in Q1 2026.

This positive opinion, from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), recommends that donidalorsen receive marketing authorization. European Commission decision expected in Q1 2026.

Brett P. Monia, Ph.D., Chief Executive Officer, Ionis, said: “We believe the positive opinion from the CHMP reflects the robust clinical evidence supporting Dawnzera and its potential to deliver a meaningful benefit to people living with HAE in the EU. This advancement is made possible by the shared dedication of the teams at Ionis and Otsuka.”

Andy Hodge, President and CEO, Otsuka Pharmaceutical Europe Ltd, said: “We are encouraged by the CHMP’s positive opinion, a key milestone in advancing access to potentially life-changing treatments for the HAE community. We look forward to the forthcoming decision from the European Commission and remain committed to addressing the unmet needs of this patient population.”

(Source: Ionis)