Shots:
- The CHMP has recommended Dawnzera for the routine prevention of HAE attacks in pts (≥12yrs.) following the US FDA approval in Aug 2025; EC’s decision is expected in Q1’26
- Opinion was based on P-III (OASIS-HAE) trial & OASISplus study, showing improvements across multiple domains, incl. sustained reduction in mean monthly HAE attack rate even when Dawnzera is self-administered via an autoinjector
- Otsuka licensed Dawnzera from Ionis in Dec 2023 for exclusive commercialization in Europe & later, in June 2024, secured exclusive rights for the APAC region, incl. Japan
Ref: Ionis | Image: Ionis and Otsuka | Press Release
Related News:- Ionis Highlights P-III (CORE & CORE2) Trials Results of Olezarsen for Severe Hypertriglyceridemia (sHTG) at AHA 2025
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