- Health Canada has approved Empaveli (pegcetacoplan) as the first treatment for C3G or primary IC-MPGN in patients aged ≥12 years in Canada, aimed at reducing proteinuria
- The approval is backed by the Phase 3 VALIANT study, which showed a ~68% reduction in proteinuria (uPCR), stabilization of kidney function, and meaningful clearance of C3 deposits over 52 weeks
- Developed by Swedish Orphan Biovitrum AB, Empaveli is a targeted C3 inhibitor designed to control overactivation of the complement system, a key driver of disease progression
- C3G and primary IC-MPGN affect ~700 patients in Canada, with >50% progressing to kidney failure within 5–10 years; Sobi and Apellis Pharmaceuticals co-develop pegcetacoplan globally to expand access in this high unmet-need population
- Takeaways:
Empaveli’s C3G/IC‑MPGN nod makes Sobi/Apellis the first movers in complement‑mediated kidney disease in Canada, turning a ~700‑patient ultra‑rare population into a high‑value, premium‑priced niche anchored on strong VALIANT data.
Source: Globenewswire