Vera Therapeutics Announces U.S. FDA Granted Priority Review to Biologics License Application for Atacicept for Treatment of Adults with IgA Nephropathy

Core Viewpoint - Vera Therapeutics announced that the Biologics License Application (BLA) for atacicept, aimed at treating adults with immunoglobulin A nephropathy (IgAN), has been accepted for Priority Review by the FDA, with a target action date of July 7, 2026. If approved, atacicept will provide a self-administered, once-weekly subcutaneous injection for patients [1][7]. Company Overview - Vera Therapeutics is a late clinical-stage biotechnology company focused on developing transformative treatments for serious immunological diseases, with atacicept as its lead product candidate [11]. Product Details - Atacicept is an investigational recombinant fusion protein that targets B-cell Activating Factor (BAFF) and A Proliferation-Inducing Ligand (APRIL), which are cytokines involved in the production of autoantibodies associated with IgAN and other autoimmune kidney diseases [4][11]. - The drug is designed for at-home self-administration, allowing patients to receive treatment conveniently [1][11]. Clinical Trial Results - The BLA submission for atacicept is supported by data from the ORIGIN 3 trial, which demonstrated a 46% reduction in proteinuria from baseline and a statistically significant 42% reduction compared to placebo at week 36 [2][5]. - The ORIGIN Phase 2b clinical trial met its primary and key secondary endpoints, showing significant proteinuria reductions and stabilization of estimated glomerular filtration rate (eGFR) compared to placebo [5][6]. Regulatory Status - Atacicept has received FDA Breakthrough Therapy Designation for IgAN, indicating its potential to provide substantial improvement over existing therapies [9][7]. - The FDA's Priority Review designation highlights the urgent need for new therapies in the IgAN treatment landscape [2][7]. Future Prospects - The ongoing ORIGIN 3 trial involves 431 adults with IgAN and aims to evaluate the long-term effects of atacicept on kidney function, with results expected in 2027 [6][8]. - Vera Therapeutics is also exploring atacicept's efficacy in other autoimmune diseases, expanding its potential market [10][11].