Otsuka wins EC approval for Dawnzera
The European Commission (EC) has granted marketing authorization for Dawnzera (donidalorsen) for the routine prevention of recurrent attacks of hereditary angioedema (HAE) in adults and adolescents aged 12 years and older, the European unit of Japanese drugmaker Otsuka (TYO: 4578) today announced.
The approval marks the first European-approved RNA-targeted therapy for HAE, a genetic condition which causes unpredictable swelling episodes that can affect the extremities, face, abdomen, genitals and the larynx, imposing significant burden on patients and their families. The decision follows the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) in November 2025.
Clinical backing
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