07:38 AM EST, 01/21/2026 (MT Newswires) -- Ionis Pharmaceuticals ( IONS ) and Otsuka Pharmaceutical have received European Commission approval for Dawnzera, or donidalorsen, for the routine prevention of recurrent attacks of hereditary angioedema in adults and adolescents aged 12 and older, Ionis said Wednesday.
Dawnzera is self-administered via subcutaneous autoinjector every four or eight weeks, the company said.
The approval follows a positive opinion from the Committee for Medicinal Products for Human Use and is based on phase 3 trial results showing a "significant and sustained" reduction in mean monthly HAE attack rates, including a 94% overall reduction at one year in the OASISplus open-label extension study, Ionis said.
Ionis shares were up more than 1% in recent pre-bell activity Wednesday.