Vera Therapeutics' Trutakna Wins Accelerated FDA Approval, Positioning for Critical Q3 eGFR Confirmatory Test
On July 7, 2026, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Vera Therapeutics' TRUTAKNA (atacicept-vymj) to reduce proteinuria in adults with primary IgA nephropathy (IgAN) at risk for disease progression. TRUTAKNA is a first-in-class soluble recombinant fusion protein that binds to and inhibits both B-cell activating factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL), making it the first approved therapy to target these two key upstream cytokines driving IgAN pathophysiology.
The accelerated approval was supported by a prespecified 36-week interim analysis of the ongoing Phase 3 ORIGIN 3 trial (Vera Therapeutics' Trutakna Wins Accelerated FDA Approval, Positioning for Critical Q3 eGFR Confirmatory Test):
- Participants treated with weekly subcutaneous 150 mg TRUTAKNA achieved a 46% reduction from baseline in proteinuria (urine-protein-to-creatinine-ratio / UPCR).
- This represented a statistically significant and clinically meaningful 42% reduction compared to placebo (p<0.0001) at 36 weeks.
- TRUTAKNA-treated patients also demonstrated a 68% reduction in galactose-deficient IgA1 (Gd-IgA1) and resolution of hematuria in 81% of patients who had hematuria at baseline.
Commercial Launch and Next Regulatory Steps
In its Q2 2026 business and financial update released on August 10, 2026, Vera Therapeutics reported that the U.S. commercial launch is actively underway. The company has structured its patient support program, TRUTAKNA TRU SUPPORT™, to ensure broad access.
Crucially, Vera has aligned with the FDA on pulling forward the final efficacy analysis of the Phase 3 ORIGIN 3 trial to Q3 2026. This analysis will evaluate change in kidney function as measured by estimated glomerular filtration rate (eGFR) and will serve as the confirmatory data required to support full approval.1 Vera plans to submit a supplemental Biologics License Application (sBLA) in Q4 2026, targeting potential full FDA approval in 2027.
Dr. Marshall Fordyce, Founder and CEO of Vera Therapeutics, stated:
"We are thrilled that TRUTAKNA is available to eligible patients as the first and only therapy to inhibit both BAFF and APRIL in IgAN patients. We are focused on a successful U.S. launch of TRUTAKNA, and we continue to advance the ORIGIN 3 program in support of a potential full approval."
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An instance of Full clinical approval requires stabilizing physiological decline rather than temporarily reducing surrogate biomarkers. — The FDA requires long-term proof of stabilized glomerular filtration rates, rather than transient protein reductions, to transition the therapy to full approval. ↩︎