FDA approves Atacicept for Adults with Primary IgA Nephropathy

The FDA approved atacicept-vymj (Trutakna, Vera Therapeutics) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. Atacicept was granted accelerated approval based on reduction of proteinuria, according to the FDA. The agency’s 2026 novel drug approvals list identifies atacicept as the 24th novel drug approved by the FDA’s Center for Drug Evaluation and Research this year.

The efficacy and safety of atacicept were evaluated in an ongoing randomized, double-blind, placebo-controlled clinical trial (ORIGIN 3) in adults with biopsy-confirmed IgAN. Participants were randomly assigned to receive atacicept 150mg injected subcutaneously once weekly or placebo. The primary efficacy endpoint assessed change from baseline in proteinuria, measured by urine protein-to-creatinine ratio (UPCR) from a 24-hour urine collection, after 9 months of treatment in the first 203 patients who had the opportunity to reach the month 9 visit. 

Patients receiving atacicept had an average 46% reduction in proteinuria at 9 months. Vera Therapeutics reported that, in a prespecified 36-week interim analysis of the ORIGIN 3 trial, participants treated with atacicept achieved a 46% reduction from baseline in UPCR and a 42% reduction compared with placebo (P<.0001) and that atacicept was generally well tolerated, with infections and local reactions listed as the most common adverse reactions.

The FDA said atacicept suppresses the immune system and may increase the risk of infections. The agency also noted that it has not been established whether atacicept slows long-term kidney function decline in IgAN, and continued approval may depend on verification of clinical benefit in the ongoing confirmatory trial.

Sources: Vera Therapeutics. Vera Therapeutics receives FDA accelerated approval for TRUTAKNA™ for adult patients with primary IgA nephropathy. Press release. Vera Therapeutics; July 7, 2026. Accessed July 9, 2026.

Food and Drug Administration. FDA approves new treatment to reduce proteinuria in adults with primary immunoglobulin A nephropathy. News release. Food and Drug Administration; July 7, 2026. Accessed July 9, 2026.

Food and Drug Administration. Novel drug approvals for 2026. Food and Drug Administration. Accessed July 9, 2026.