EU Approves DawnZera for Hereditary Angioedema, Ionis and Otsuka Say

The European Commission has approved DawnZera (ecallantide) for the treatment of hereditary angioedema in adults, according to Ionis Pharmaceuticals and Otsuka Pharmaceutical. The approval marks the first regulatory green light for the drug in the EU, effective January 20, 2026. DawnZera is a kallikrein inhibitor designed to prevent acute attacks in patients with hereditary angioedema. The decision was based on data from Phase 3 trials showing a 78% reduction in attack rates compared to placebo over 12 months. Ionis and Otsuka expect commercial launch across EU member states by Q2 2026. Shares of Ionis (IONS) rose 4.2% in after-hours trading following the announcement.