FDA Grants Priority Review Of Biologics License Application For Atacicept In IgA Nephropathy

The US Food and Drug Administration (FDA) has granted priority review to the Biologics License Application (BLA) for atacicept for the treatment of adults with IgA nephropathy (IgAN).1

The decision was announced on January 7, 2026, with a Prescription Drug User Fee Act target action date set for July 7, 2026. If approved, atacicept would offer patients an autoinjector for at-home self-administration of a once-weekly subcutaneous injection.1

Atacicept is an investigational recombinant fusion protein, containing the soluble transmembrane activator and calcium-modulating cyclophilin ligand interactor receptor, which binds to the cytokines B-cell activating factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL). BAFF and APRIL are members of the tumor necrosis superfamily, playing crucial roles in immune system regulation, and promote B-cell survival and autoantibody production associated with IgAN, lupus nephritis, and other autoimmune kidney diseases.1

“Atacicept offers a distinct approach through dual targeting of BAFF and APRIL, which we believe could advance the standard of care in IgAN, if approved,” said Marshall Fordyce, MD, founder and CEO of Vera Therapeutics, in a company statement. “FDA’s Priority Review designation reinforces the need for new therapies that can reshape the IgAN treatment landscape. We remain committed to working with the FDA to facilitate a thorough review of the BLA. Our team is focused on bringing a potential treatment to patients with the urgency they deserve.”1

The BLA submission was supported by data from the ORIGIN 3 trial’s prespecified interim analysis. The phase 3 trial met its primary endpoint of reduction in proteinuria at week 36 in June 2025, with a 46% reduction compared to baseline, and a 42% reduction compared to placebo (P < .0001). According to study investigators, these results were consistent and improved from the ORIGIN phase 2b trial.1,2

During the randomized trial period, the safety profile was comparable between atacicept and placebo. Through 96 weeks, atacicept demonstrated further improvements in Gd-IgA1, hematuria, and proteinuria, as well as stabilization of estimated glomerular filtration rates (eGFR).1,2

“ORIGIN 3 is the first Phase 3 clinical trial in IgAN to demonstrate this magnitude of UPCR reduction compared to placebo at week 36. These results convincingly demonstrate the impact of atacicept to reduce proteinuria,” said Richard Lafayette, MD, FACP, a professor of medicine, nephrology, and director of the Glomerular Disease Center at Stanford University Medical Center, and a primary investigator for both ORIGIN 2b and ORIGIN 3, in a previous statement.2

ORIGIN 3 is an ongoing global, multicenter, randomized, double-blind, placebo-controlled Phase 3 trial of 431 adults with IgAN, where participants were randomized in a 1:1 ratio to atacicept 150 mg, self-administered at home via once weekly subcutaneous injection, or placebo. The placebo-controlled, blinded trial will continue to evaluate the change in kidney function over 2 years as measured by eGFR, with results expected in 2027.1

References

1. Therapeutics V. Vera Therapeutics Announces U.S. FDA Granted Priority Review to Biologics License Application for Atacicept for Treatment of Adults with IgA Nephropathy. GlobeNewswire News Room. Published January 7, 2026. Accessed January 7, 2026. https://www.globenewswire.com/news-release/2026/01/07/3214426/0/en/Vera-Therapeutics-Announces-U-S-FDA-Granted-Priority-Review-to-Biologics-License-Application-for-Atacicept-for-Treatment-of-Adults-with-IgA-Nephropathy.html

2. Vera Therapeutics Announces Atacicept Achieved 46% Proteinuria Reduction in ORIGIN Phase 3 Trial in Adults with IgA Nephropathy | Vera Therapeutics. Vera Therapeutics. Published 2025. Accessed January 7, 2026. https://ir.veratx.com/news-releases/news-release-details/vera-therapeutics-announces-atacicept-achieved-46-proteinuria

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