VERA News & Events

The U.S. Food and Drug Administration has approved Trutakna to reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk for disease progression. Trutakna is injected subcutaneously once weekly. The efficacy and safety of Trutakna were evaluated in a randomized, double-blind, placebo-controlled clinical trial in adults with biopsy-confirmed IgA nephropathy. Patients were randomly assigned to either Trutakna 150 mg injected subcutaneously once weekly or placebo. The primary efficacy endpoint assessed the change from baseline in proteinuria after 9 months of treatment in the first 203 patients who had the opportunity to reach the month 9 visit. At 9 months, patients in the Trutakna group had an average 46% reduction in proteinuria as compared to an proteinuria in the placebo group. The FDA approval was granted to Vera Therapeutics.

Vera Therapeutics announced it has aligned with the U.S. Food and Drug Administration on a revised, earlier ORIGIN 3 eGFR analysis plan to support full approval for atacicept in adults with IgAN. "The eGFR results are now expected in the third quarter of 2026. Pending these results, Vera Therapeutics plans to submit an sBLA for full approval in the fourth quarter of 2026. Alignment with the FDA on a revised eGFR analysis plan follows a recent workshop hosted by the National Kidney Foundation which included clinicians, researchers, regulators, and patient advocates. In addition, the alignment with the FDA has been supported by the eGFR results from the ORIGIN Phase 2b trial of atacicept in IgAN," the company stated. "We are excited for the potential to deliver the first approved therapy targeting both BAFF and APRIL in adults with IgAN, and to bring forward the eGFR analysis to potentially support full approval of atacicept in this indication at an earlier date," said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics.