Vertex Receives FDA Acceptance for Povetacicept Application in IgA Nephropathy
2 June 2026
Vertex Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for povetacicept, an investigational treatment for adults with immunoglobulin A nephropathy (IgAN).
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of 30 November 2026. If approved, povetacicept would become the first commercial product in Vertex’s nephrology portfolio.
The application is supported by positive results from a pre-specified Week 36 interim analysis of the ongoing Phase III RAINIER trial. The study evaluated povetacicept in patients with IgAN and demonstrated a statistically significant reduction in proteinuria, an important indicator of kidney disease progression, compared with placebo.
The trial met its primary endpoint, with patients receiving povetacicept achieving a 52.0% reduction from baseline in urine protein-to-creatinine ratio (UPCR) at Week 36. Compared with placebo, the treatment produced a 49.8% reduction in UPCR, with results reaching statistical significance.
The reduction in proteinuria was consistent across all pre-specified patient subgroups.
The study also met its secondary endpoints. Patients treated with povetacicept recorded a 77.4% reduction from baseline in serum galactose-deficient IgA1 (Gd-IgA1), compared with a 9.1% increase in the placebo group. This represented a 79.3% reduction compared with placebo.
Among patients who had haematuria at baseline, 85.1% of those receiving povetacicept achieved haematuria resolution, compared with 23.4% of patients in the placebo group.
Povetacicept was generally well tolerated during the study. Most adverse events were mild to moderate in severity, and no treatment-related serious adverse events were reported. Anti-drug antibodies were observed, as expected, but they did not affect efficacy or safety outcomes.
If approved, Vertex plans to launch povetacicept as a low-volume subcutaneous auto-injector administered once every four weeks at home.
Source: businesswire.com
