Shots:
- The US FDA has approved Dawnzera (donidalorsen; 80mg SC, Q4W/Q8W) as a prophylactic treatment against attacks in pts (≥12yrs.) with hereditary angioedema; available in the US in coming days
- Approval was based on P-III (OASIS-HAE) trial & OASISplus OLE study, where P-III showed 81% fewer monthly HAE attacks over 24wks. (87% from 2nd dose) & ~90% fewer mod. to sev. attacks, while OLE showed Q8W matched Q4W, with 94% reduction after 1yr.
- OASISplus also incl. a switch cohort of pts previously treated with lanadelumab, C1-esterase inhibitor, or berotralstat for ≥12wks. who switched to Dawnzera (Q4W) & observes a 62% attack rate reduction over 16wks. with no increase in breakthrough attacks; 84% preferred Dawnzera for better control, convenience, & less pain
Ref: Ionis| Image: Ionis | Press Release
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