ACCELERATED APPROVAL

FDA grants accelerated approval to Vera's TRUTAKNA for IgA nephropathy

The approval rests on a 42% proteinuria reduction versus placebo from an interim ORIGIN 3 analysis, making TRUTAKNA the first dual BAFF and APRIL inhibitor cleared for the disease.

By AppliedXLJuly 7, 2026Trial NCT04716231

Executive Summary

The FDA granted accelerated approval to Vera Therapeutics' atacicept-based therapy for IgA nephropathy, converting a Phase 3 interim result into the first authorized dual BAFF and APRIL inhibitor for the disease.
The approval landed on the FDA's original target action date, with no slippage from the timeline the agency set when it accepted the filing for priority review.
The clearance rests on a placebo-controlled interim analysis showing a proteinuria reduction that cleared statistical significance, the surrogate measure accelerated approval in this disease is built around.
Because the approval used a surrogate endpoint, it comes with a confirmatory trial obligation, and the mechanism competes in a field where most prior programs targeting the same pathway in this indication have not reached approval.

The decision

Vera Therapeutics, Inc. said on July 7, 2026 that the FDA granted accelerated approval to TRUTAKNA to reduce proteinuria in adults with primary IgA nephropathy at risk for disease progression. The approval traces to a prespecified interim analysis of the ongoing Phase 3 ORIGIN 3 trial (NCT04716231), in which patients on TRUTAKNA achieved a 46% reduction from baseline in proteinuria and a 42% reduction relative to placebo, measured by 24-hour urine protein-to-creatinine ratio at week 36, a result the company called statistically significant with p<0.0001. The drug is dosed as a 150 mg weekly subcutaneous injection, self-administered by patients through an autoinjector. The decision arrived on the FDA's original July 7, 2026 target action date, the same date the agency set when it accepted the biologics license application for priority review in January 2026, with no delay across five recorded guidance updates in between. Vera+2

The stake

IgA nephropathy is a progressive, immune-mediated kidney disease that Vera estimates affects approximately 160,000 people in the United States, with at least half of patients eventually progressing to end-stage kidney disease or kidney failure. "The approval of TRUTAKNA as the first and only BAFF and APRIL inhibitor for IgAN marks an important milestone," said Marshall Fordyce, M.D., founder and chief executive of Vera Therapeutics. Richard Lafayette, M.D., a principal investigator in the ORIGIN clinical program and director of the Glomerular Disease Center at Stanford University Medical Center, said the drug "inhibits both BAFF and APRIL, the two key cytokines that act on B cells, which are at the source of IgAN pathophysiology". The trial reported adverse reactions concentrated in infections and local injection-site reactions, with a safety profile the company described as comparable to placebo. Vera

The competitive field

TRUTAKNA enters a field where BAFF-pathway inhibition has been tested repeatedly in IgA nephropathy without full approval until now. Eight direct comparators sharing the BAFF target or mechanism class are in active clinical testing for the same or an adjacent indication, including Novartis's zigakibart (NCT06858319) and Otsuka's sibeprenlimab (NCT05248659), both in Phase 3 IgA nephropathy trials, alongside Vertex's povetacicept and Vor Biopharma's telitacicept in related autoimmune indications. Within this same target-and-indication class, 75% of resolved trials terminated rather than completed, with three distinct sponsors recording failures, a base rate drawn from a small set of four resolved programs. Against that history, TRUTAKNA is the first to clear a regulatory decision rather than stall in development, though its clearance rests on the same surrogate measure that has not yet been confirmed to durably slow kidney function loss in this trial.

What comes next

Accelerated approval on a surrogate endpoint carries a standing confirmatory trial obligation under federal law, with the risk of withdrawal if the confirmatory data does not verify the clinical benefit. The company's earlier announcement of Breakthrough Therapy Designation for atacicept in this disease, granted based on Phase 2b ORIGIN data, reinforced the agency's read on unmet need. ORIGIN 3 remains active and not recruiting, with a primary completion date of May 15, 2025 already passed and full completion not projected until July 2028, meaning the trial that supported this interim-based approval is still generating the longer-term data the confirmatory requirement will draw on. Vera+1

This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.