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Vertex’s biologics application for povetacicept in IgA nephropathy accepted by US FDA
Tuesday, June 02, 2026
Vertex Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for povetacicept, an investigational engineered fusion protein being developed for the treatment of 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 3 RAINIER trial. The study showed that povetacicept achieved a statistically significant and clinically meaningful reduction in proteinuria, a key indicator of kidney disease progression, compared with placebo.
According to the trial results, patients receiving povetacicept recorded a 52.0% reduction from baseline in urine protein-to-creatinine ratio (UPCR) at Week 36. The treatment demonstrated a 49.8% greater reduction in UPCR compared with placebo, meeting the study’s primary endpoint.
The trial also met its secondary endpoints. Patients treated with povetacicept achieved a 77.4% reduction from baseline in serum galactose-deficient IgA1 (Gd-IgA1), compared with a 9.1% increase in the placebo group. In addition, among patients with haematuria at baseline, 85.1% experienced resolution of the condition, compared with 23.4% of patients receiving placebo.
Povetacicept was generally well tolerated during the study, with most adverse events reported as mild to moderate. No serious adverse events related to the treatment were observed. Anti-drug antibodies were detected as expected, but they did not affect treatment efficacy or safety.
If approved, Vertex plans to commercialise povetacicept as a low-volume subcutaneous auto-injector administered once every four weeks at home.
Source: businesswire.com
