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Reporting 1-year results from the corresponding open-label extension (OLE) cohort of the OASISplus study (NCT05392114) for Donidalorsen.

Reported Monday, Jul 21 - 7:07am EDT (TheFly subscription required to read more.)

Ionis Pharmaceuticals (Nasdaq: IONS) and Otsuka announced the CHMP has adopted a positive opinion for DAWNZERA (donidalorsen) for routine prevention of hereditary angioedema (HAE) in adults and adolescents aged 12 and older.The opinion is now with the European Commission, with a decision expected in Q1 2026. CHMP based its recommendation on Phase 3 OASIS-HAE and OASISplus results showing a significant, sustained reduction in mean monthly HAE attack rate, including with autoinjector self-administration. DAWNZERA received FDA approval in August 2025.

Phase 3 data reveals superior efficacy for HAE patients switching to donidalorsen. FDA decision expected August 21. See detailed patient preference and QoL improvements.

Ionis’ Dawnzera received FDA approval based on data from the Phase III OASIS-HAE trial and ongoing OASISplus extension studies. These trials showed that

– Patients switched to donidalorsen without increased breakthrough attacks and experienced further reductions in mean attack rate from baseline – – 84% of patients surveyed preferred donidalorsen over their prior treatment – – Donidalorsen is currently under review with the U.S. FDA as a potential first-in-class prophylactic treatment for HAE; PDUFA date August 21 – …