Novartis Vanrafia Cuts eGFR Decline by 2.39 ml/min in Phase III
Phase III ALIGN data showed Vanrafia-treated IgAN patients had a 2.39 ml/min/1.73 m² slower eGFR decline versus placebo at Week 136 and a 2.59 ml/min benefit at Week 132 in those on SGLT2 inhibitors. Vanrafia received accelerated U.S. and China approval for proteinuria reduction in April 2025; Novartis intends traditional approval submission in 2026.
1. Phase 3 ALIGN Study Results
Novartis reported that Vanrafia slowed kidney function decline by 2.39 ml/min/1.73 m² versus placebo at Week 136 (two-sided p=0.057) and by 2.59 ml/min/1.73 m² at Week 132, with the prespecified exploratory subgroup on SGLT2 inhibitors showing clinically meaningful benefit and safety consistent with prior studies.
2. Regulatory Pathway
Vanrafia received accelerated approval in the U.S. and China in April 2025 for reduction of proteinuria in IgAN patients, with continued approval contingent on verifying long-term clinical benefit; Novartis plans to submit for traditional FDA approval in 2026 based on ALIGN data.
3. IgAN Portfolio and Next Steps
Novartis is advancing a multi-asset IgAN strategy alongside Vanrafia, including approved iptacopan (Fabhalta) and investigational zigakibart, to address disease progression and expand treatment options for patients with chronic IgA nephropathy.