BRISBANE, Calif., July 7, 2026
Vera Therapeutics, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted Accelerated Approval to TRUTAKNA™ (atacicept-vymj) for the treatment of adult patients with primary Immunoglobulin A Nephropathy (IgAN) who are at risk of disease progression. The approval marks a significant milestone in autoimmune kidney disease treatment, making TRUTAKNA the first and only approved therapy that simultaneously inhibits both B-cell Activating Factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL)—two critical immune signaling molecules involved in the underlying pathophysiology of IgAN. The therapy is administered as a 150 mg once-weekly subcutaneous injection using a patient-friendly autoinjector designed for home administration. The FDA’s decision was supported by positive interim Phase 3 clinical data demonstrating substantial reductions in proteinuria, a recognized surrogate marker associated with slowing kidney disease progression.
Phase 3 ORIGIN Trial Demonstrates Strong Clinical Benefit
The accelerated approval is based on the ongoing global ORIGIN 3 Phase 3 clinical trial, a randomized, double-blind, placebo-controlled study evaluating TRUTAKNA in adults with primary IgA nephropathy. In the prespecified interim analysis, patients receiving TRUTAKNA achieved a remarkable 46% reduction in proteinuria from baseline, with a 42% statistically significant reduction compared with placebo after 36 weeks of treatment. The therapeutic benefit remained consistent across multiple patient subgroups, including age, sex, race, geographic region, baseline kidney function, and concomitant SGLT2 inhibitor use. Investigators also observed a 68% reduction in galactose-deficient IgA1 (Gd-IgA1), an important biomarker implicated in disease progression.
Safety findings further strengthened the clinical profile of TRUTAKNA, with the therapy being generally well tolerated throughout the study. The most commonly reported adverse events were mild infections and local injection-site reactions, while no serious opportunistic infections, severe immunosuppression, or clinically meaningful anti-drug antibody effects were reported during the 36-week evaluation period. Although the approval is based on proteinuria reduction, continued FDA approval will depend on confirmation of long-term clinical benefit through ongoing evaluation of kidney function decline measured by estimated glomerular filtration rate (eGFR).
First Dual BAFF and APRIL Inhibitor Advances Kidney Disease Care
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Primary IgA Nephropathy (IgAN) is a serious, progressive immune-mediated kidney disease and one of the leading causes of chronic kidney disease and kidney failure worldwide. Approximately 160,000 patients in the United States are estimated to be living with IgAN, while many patients progress to kidney failure or require dialysis and kidney transplantation within two decades of diagnosis. TRUTAKNA’s novel mechanism of action distinguishes it from existing therapies by simultaneously blocking BAFF and APRIL, cytokines responsible for activating B cells that produce pathogenic galactose-deficient IgA1 antibodies. By targeting these disease-driving immune pathways at their source, the therapy aims to reduce immune complex formation and kidney inflammation before irreversible damage occurs.
Vera Therapeutics also announced the launch of its TRUTAKNA TRU SUPPORT™ patient assistance program to improve access through insurance guidance, educational resources, and financial assistance for eligible patients. The FDA approval establishes Vera Therapeutics as a commercial-stage biotechnology company while introducing an innovative biologic therapy that could significantly reshape the treatment landscape for IgA nephropathy. As the confirmatory Phase 3 ORIGIN study continues toward evaluation of long-term kidney function outcomes, TRUTAKNA represents an important advancement in precision immunology and autoimmune kidney disease management, offering physicians and patients a first-in-class therapeutic option designed to address the underlying immune mechanisms driving disease progression.
Source: Vera Therapeutics press release
