- CELYSTRA Pharma has received Health Canada approval for Dawnzera (donidalorsen) to prevent hereditary angioedema (HAE) attacks in adults and pediatric patients aged 12 years and older.
- The RNA-targeted therapy reduces plasma prekallikrein production and is self-administered subcutaneously at 80 mg once every four or eight weeks.
- In the Phase 3 OASIS-HAE study, Dawnzera Q4W reduced monthly HAE attack rates by 81% vs. placebo over 24 weeks, with an 87% reduction from the second dose.
- CELYSTRA has initiated reimbursement reviews with CDA and INESSS; Dawnzera is expected to be commercially available in Canada in the coming months.
Takeaways:
Health Canada’s approval of Dawnzera (donidalorsen) gives CELYSTRA a first‑in‑class, RNA‑targeted prophylaxis for hereditary angioedema (HAE) in patients ≥12 years, with Q4W/Q8W subcutaneous dosing and an 81% attack‑rate reduction vs placebo in OASIS‑HAE—positioning it against established kallikrein/bradykinin‑pathway preventives (e.g., Takhzyro, Orladeyo) in a global HAE market estimated at ~US$6.8B in 2026 and projected to reach ~US$14.7B by 2031 (~16.5% CAGR). With reimbursement reviews underway (CDA/INESSS) and commercial launch expected in coming months, Dawnzera can capture share among patients seeking less‑frequent, self‑administered prophylaxis, though uptake will depend on pricing, formulary listings and competition from Takeda’s dominant franchise.
Source: CA Newswire
