21 January 2026 - Otsuka announces that the European Commission has granted marketing authorization for Dawnzera (donidalorsen) for the routine prevention of recurrent attacks of hereditary angioedema in adults and adolescents aged 12 years and older.

The pivotal, double-blind, placebo-controlled, Phase 3 OASIS-HAE study (n=90) showed the use of donidalorsen 80 mg every four weeks led to an 81% reduction in 4-weekly HAE attack rate compared to placebo (mean attack rates 0.44 vs. 2.26 respectively) over 24 weeks, meeting the study's primary outcome. 

Read Otsuka press release