On January 21, 2026, the European Commission approved DAWNZERA™ (donidalorsen) as the first RNA-targeted preventive treatment for hereditary angioedema (HAE) in adults and adolescents aged 12+.
Developed by Ionis Pharmaceuticals and commercialized in Europe by Otsuka, Dawnzera targets plasma prekallikrein to reduce HAE attacks.
It’s given subcutaneously every 4 or 8 weeks via autoinjector, making it convenient for self-administration.
Approval rests on Phase 3 data from the OASIS-HAE and OASISplus studies, including a 94% mean reduction in monthly attack rates in the long-term extension.
Ionis CEO Brett Monia called it “a major milestone” for RNA therapeutics, while Otsuka emphasized the collaboration’s impact on this rare, debilitating disease.
Dawnzera, already FDA-approved in the US (August 2025), now offers EU patients a new option to significantly cut attack frequency and improve quality of life.
Treatments for Hereditary Angioedema (HAE) (click to enlarge the image).