Otsuka’s Dawnzera Wins European Commission Approval for Hereditary Angioedema Prevention

Otsuka Pharmaceutical, in partnership with Ionis Pharmaceuticals, has secured European Commission approval for Dawnzera (donidalorsen) in the European Union as a preventative treatment for hereditary angioedema (HAE) in adults and adolescents aged 12 and older. This decision comes after a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use, which reviewed data demonstrating that Dawnzera can significantly reduce the frequency of debilitating HAE attacks.

The medication is designed to be self-administered by patients via pre-filled injection pens at multi-week intervals, offering convenience alongside clinical benefit. Trials showed substantial reductions in attack rates versus placebo, supporting its use as a routine prophylactic therapy. The approval marks a major milestone for the rare disease community in Europe by bringing a novel RNA-targeted therapeutic option to patients who often face unpredictable and painful swelling episodes. Dawnzera already holds approval in the United States for the same indication and represents an important step forward in expanding access to innovative care for people living with HAE.