FDA Approves Atacicept (Trutakna) for IgA Nephropathy

The US Food and Drug Administration (FDA) has granted accelerated approval to atacicept (Trutakna) to reduce proteinuria in adults with primary IgA nephropathy (IgAN) at risk for disease progression, offering patients an autoinjector for at-home self-administration of a once-weekly subcutaneous injection.

Vera Therapeutics announced the decision on July 7, 2026, which was supported by data from a prespecified interim analysis of the ORIGIN 3 trial, where participants treated with atacicept achieved a 46% reduction from baseline in proteinuria, with a statistically significant and clinically meaningful 42% reduction compared to placebo (P <.0001) at 36 weeks.

Of note, the accelerated approval is based on reduction of proteinuria, and it has not been established whether atacicept slows kidney function decline over the long-term in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the ongoing ORIGIN 3 trial, which continues in a placebo-controlled, blinded manner to evaluate change in kidney function as measured by estimated glomerular filtration rate (eGFR), with results anticipated in Q3 2026.

“I frequently hear from IgAN patients who are uncertain about what this disease may mean for their future, reflecting the historic high risk of poor outcomes with standard therapies,” Richard Lafayette, MD, FACP, Professor of Medicine, Nephrology and Director of the Glomerular Disease Center at Stanford University Medical Center, and a principal investigator in the ORIGIN clinical program, said in a statement. “[Atacicept] offers patients and their nephrologists an exciting new treatment advancement that inhibits both BAFF and APRIL, the two key cytokines that act on B cells, which are at the source of IgAN pathophysiology.”

ORIGIN 3 Trial Shows Significant Proteinuria Reduction With Atacicept

The phase 3 ORIGIN trial is an ongoing global, multicenter, randomized, double-blind, placebo-controlled trial, including 431 adult patients with IgA nephropathy. Investigators randomized participants 1:1 to atacicept 150 mg, self-administered once weekly at home through subcutaneous injection, or placebo.

The primary efficacy endpoint of the prespecified 36-week interim analysis was the change in 24-hour urine-protein-to-creatinine-ratio (UPCR) compared to placebo in the first 203 participants who had received at least 1 dose of atacicept or placebo. Participants treated with atacicept achieved a 46% reduction from baseline in UPCR, with a statistically significant and clinically meaningful 42% reduction compared to placebo (P <.0001) at 36 weeks. Proteinuria efficacy was consistent across prespecified subgroups of age, sex, race, region, baseline proteinuria, baseline eGFR, and baseline SGLT2i use.

Participants who received atacicept also experienced a 68% reduction in galactose-deficient IgA1 (Gd-IgA1), a secondary endpoint with observational results due to the absence of multiplicity adjustment. or placebo. ¹

Atacicept Safety Profile Comparable With Placebo

According to the results, the safety profile of atacicept was comparable with placebo, with 59.3% of patients treated with atacicept experiencing adverse events and 50.0% in the placebo group.

Confirmatory Data From ORIGIN 3 Needed to Verify Long-Term Benefit

Although the approval enables immediate use of atacicept in eligible adults with IgAN, the ORIGIN 3 trial will continue to evaluate long-term kidney function through 2 years using eGFR as the confirmatory endpoint.

“The approval of [atacicept] as the first and only BAFF and APRIL inhibitor for IgAN marks an important milestone and we believe it has the potential to meaningfully transform the treatment landscape. We believe [atacicept] offers a novel approach to addressing this serious disease and has the potential to advance care for patients with this significant unmet medical need,” said Marshall Fordyce, MD, Founder and CEO of Vera Therapeutics. “We are grateful to the patients, investigators, study teams and regulators whose efforts made this achievement possible.”

References

1. Vera Therapeutics. Vera Therapeutics Receives FDA Accelerated Approval for TRUTAKNA™ for Adult Patients with Primary IgA Nephropathy. July 7, 2026. Accessed JulyP7, 2026. https://ir.veratx.com/news-releases/news-release-details/vera-therapeutics-receives-fda-accelerated-approval-trutaknatm

2. Lafayette R, Barbour SJ, Brenner RM, et al. A Phase 3 Trial of Atacicept in Patients with IgA Nephropathy. New England Journal of Medicine. Published online November 6, 2025. doi:10.1056/nejmoa2510198