FDA Approves Atacicept for IgA Nephropathy

The FDA has approved atacicept-vymj (Trutakna; Vera Therapeutics) for adults with immunoglobulin A nephropathy (IgAN), making it the first dual B-cell activating factor (BAFF)/A proliferation-inducing ligand (APRIL) inhibitor cleared for the progressive kidney disease.¹ The approval gives nephrologists and payers a new self-administered option for a condition that, if left uncontrolled, pushes at least half of patients toward kidney failure or dialysis.

The decision follows a priority review the FDA granted in January 2026, when the agency accepted Vera's biologics license application (BLA) under the Accelerated Approval Program and set a target action date of July 7.² The application was built on a prespecified interim analysis from the phase 3 ORIGIN 3 trial (NCT04716231), reflecting the agency's view that atacicept could offer a meaningful improvement over existing IgAN therapies.

What Data Supported the Approval

ORIGIN 3 enrolled 431 adults with biopsy-confirmed IgAN at sites worldwide, randomized 1:1 to atacicept 150 mg, self-administered weekly via at-home subcutaneous injection, or placebo. At the prespecified 36-week interim analysis, the primary end point—change in 24-hour urine protein-to-creatinine ratio (UPCR)—was assessed in the first 203 patients who had received at least 1 dose. Patients on atacicept achieved a 46% reduction in proteinuria from baseline, with a statistically significant, clinically meaningful 42% reduction relative to placebo (P < .0001).³ Richard Lafayette, MD, FACP, of Stanford University Medical Center, a primary investigator on the trial, called it the largest placebo-adjusted UPCR reduction shown by any phase 3 IgAN trial at week 36 to date. Results were presented as a late-breaking session at the American Society of Nephrology Kidney Week meeting and published in The New England Journal of Medicine.

Per FDA guidance, Vera withheld estimated glomerular filtration rate (eGFR) data while the placebo-controlled portion of ORIGIN 3 continued. However, following a June 2026 alignment with the FDA on a revised analysis plan, these pivotal eGFR results have been pulled forward and are now expected in the third quarter of 2026 to support potential full approval.⁴ In the registrational program, atacicept was generally well tolerated, with infections and local administration (injection-site) reactions the most common adverse reactions; infections occurred in 32% of atacicept-treated patients vs 28% with placebo, and local administration reactions in 30% vs 5%, respectively. Because atacicept suppresses the immune system and may increase infection risk, the FDA advises assessing patients for active infection before starting treatment and monitoring during therapy, and live vaccines are not recommended within 30 days before or during treatment. The drug had previously received an FDA breakthrough therapy designation for IgAN and has been dosed in more than 1500 patients across clinical trials in multiple disease areas.

Why This Approval Matters for IgAN Care

IgAN, also known as Berger disease, is the most common primary glomerular disease worldwide, and in at least half of patients it progresses to end-stage kidney disease.² As previously reported by The American Journal of Managed Care^® (AJMC^®), the disease carries a heavy burden of clinical unpredictability, and there is no validated tool to forecast which patients will progress, complicating risk-stratified treatment decisions under the Kidney Disease: Improving Global Outcomes framework.^5,6

The approval also lands amid a fast-shifting IgAN landscape. In November 2025, the FDA approved sibeprenlimab (Voyxact; Otsuka), another B-cell–pathway therapy that produced a 51% placebo-adjusted UPCR reduction at 9 months in the VISIONARY trial (NCT05248646).⁷ Atacicept's dual BAFF/APRIL mechanism distinguishes it from sibeprenlimab's APRIL-only approach, giving prescribers a meaningful choice as both drugs compete for position alongside atrasentan and other agents still generating long-term outcome data.^7,8 For health plans, that means a third or fourth disease-modifying option entering formulary discussions in under 2 years, intensifying scrutiny on comparative effectiveness and prior authorization design as IgAN shifts from a sparse pipeline to a genuinely competitive one.

What Comes Next for Patients and Payers

Vera has positioned the at-home, once-weekly autoinjector as a way to support adherence and reduce site-of-care costs relative to infused alternatives, an argument managed care stakeholders will likely test against real-world claims data as utilization grows. Because this is an accelerated approval, full approval will hinge on confirmatory kidney function data. With the ORIGIN 3 eGFR readout now accelerated to Q3 2026 and a supplemental BLA submission targeted for Q4 2026, payers should expect coverage policies and prior authorization criteria to evolve rapidly as that confirmatory data mature over the coming months. Vera has also said it plans to pursue atacicept in expanded IgAN populations and other autoimmune kidney diseases, including membranous nephropathy and focal segmental glomerulosclerosis, suggesting this approval may be the first of several decision points managed care organizations will need to track for this molecule.

References

1. FDA approves new treatment to reduce proteinuria in adults with primary immunoglobulin A nephropathy. News release. FDA. July 7, 2026. Accessed July 7, 2026. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-new-treatment-reduce-proteinuria-adults-primary-immunoglobulin-nephropathy
2. Vera Therapeutics announces U.S. FDA granted priority review to biologics license application for atacicept for treatment of adults with IgA nephropathy. News release. Vera Therapeutics. January 7, 2026. Accessed July 7, 2026. https://ir.veratx.com/news-releases/news-release-details/vera-therapeutics-announces-us-fda-granted-priority-review/
3. Vera Therapeutics announces atacicept achieved 46% proteinuria reduction in ORIGIN phase 3 trial in adults with IgA nephropathy. News release. Vera Therapeutics. June 2, 2025. Accessed July 7, 2026. https://ir.veratx.com/news-releases/news-release-details/vera-therapeutics-announces-atacicept-achieved-46-proteinuria/
4. Vera Therapeutics announces alignment with U.S. FDA on earlier ORIGIN Phase 3 analysis to support potential full approval for atacicept in adults with IgA nephropathy. News release. Vera Therapeutics. June 2, 2026. Accessed July 7, 2026. https://ir.veratx.com/news-releases/news-release-details/vera-therapeutics-announces-alignment-us-fda-earlier-origin
5. Preventing progression in IgA nephropathy: a managed care focus on emerging therapies. AJMC. March 20, 2023. Accessed July 7, 2026. https://www.ajmc.com/view/preventing-progression-in-iga-nephropathy-a-managed-care-focus-on-emerging-therapies
6. Overview of treatment landscape for IgA nephropathy: standard of care and KDIGO guidelines. AJMC. April 21, 2025. Accessed July 7, 2026. https://www.ajmc.com/view/overview-of-treatment-landscape-for-iga-nephropathy-standard-of-care-and-kdigo-guidelines
7. Shaw ML. FDA approves sibeprenlimab for immunoglobulin A nephropathy. AJMC. November 26, 2025. Accessed July 7, 2026. https://www.ajmc.com/view/fda-approves-sibeprenlimab-for-immunoglobulin-a-nephropathy
8. Lafayette R, Shaw ML. Atrasentan has promising long-term potential in IgA nephropathy: Richard Lafayette, MD, FACP. AJMC. June 24, 2025. Accessed July 7, 2026. https://www.ajmc.com/view/atrasentan-has-promising-long-term-potential-in-iga-nephropathy-richard-lafayette-md-facp