Vertex Pharmaceuticals said its Phase 3 RAINIER trial of povetacicept for IgA nephropathy (IgAN) met its primary endpoint. Results were published in the New England Journal of Medicine.
At week 36, patients treated with povetacicept had a 52% reduction in proteinuria from baseline, a key indicator of kidney damage. The reduction was statistically significant and 49.8% greater than with placebo.
The monthly at-home autoinjector was generally safe and well-tolerated. The trial also met secondary endpoints, including significant reductions in serum Gd-IgA1 and resolution of hematuria.
The U.S. Food and Drug Administration accepted Vertex's Biologics License Application for accelerated approval. The agency set a PDUFA target action date of November 30, 2026.