- Health Canada has granted NOC to Fabhalta (iptacopan) by Novartis Canada for adults with complement 3 glomerulopathy (C3G) to reduce proteinuria
- The approval is supported by the Phase 3 APPEAR-C3G trial, where Fabhalta demonstrated statistically significant and clinically meaningful proteinuria reduction at 6 months, sustained through 12 months
- Fabhalta is an oral Factor B inhibitor designed to target overactivation of the alternative complement pathway, addressing the underlying disease mechanism in C3G
- C3G is a rare progressive kidney disease with limited treatment options and a high risk of kidney failure within 10 years, making the approval an important advance for affected patients in Canada
Takeaways:
Fabhalta gives Novartis a first‑in‑class, oral, mechanism‑targeted therapy in a tiny but high‑need C3G population, creating a premium niche nephrology revenue stream anchored on strong proteinuria data and clear differentiation from supportive care alone.
For the Canadian market, the approval should shift C3G management toward earlier use of complement‑blocking drugs and drive demand for specialized nephrology centers and complement diagnostics, while HTA and payer reviews will determine how broadly this high‑cost drug is used versus being reserved for the most severely affected, rapidly progressing patients.
Source: Novartis
