Novartis’ Fabhalta® (iptacopan) meets Phase III APPLAUSE-IgAN primary endpoint in IgA nephropathy

Novartis has announced that its oral complement-factor B inhibitor Fabhalta® (iptacopan) has met the primary endpoint of the Phase III APPLAUSE‑IgAN study in adults with IgA nephropathy (IgAN). In the final analysis of the trial, patients receiving Fabhalta showed a statistically significant improvement in the annualised slope of estimated glomerular filtration rate (eGFR) decline compared with placebo over two years, indicating slowed kidney-function deterioration.

According to Novartis, Fabhalta is the first and only approved complement inhibitor for adult IgAN and the new data support its potential to delay disease progression. The study included adults with biopsy-confirmed primary IgAN who had proteinuria and were on maximally tolerated renin-angiotensin system inhibitors with or without SGLT2 inhibitors. The safety profile was consistent with earlier reports. With these results, Novartis intends to leverage the data for a full regulatory submission in 2026 and continues to advance its broader IgAN portfolio, which also includes an endothelin A antagonist and an anti-APRIL antibody.