Trutakna (Atacicept) Confirmatory ORIGIN 3 Data Lands: eGFR Stabilized, 76% Progression Risk Cut — Full-Approval sBLA Planned Q4 2026
On July 7, 2026, the FDA granted accelerated approval to Vera Therapeutics' TRUTAKNA (atacicept-vymj) — the first and only approved BAFF/APRIL inhibitor — to reduce proteinuria in adults with primary IgA nephropathy (IgAN), with continued approval contingent on confirmatory verification of clinical benefit. On September 15, 2026, Vera delivered that confirmatory evidence: the final efficacy analysis of the Phase 3 ORIGIN 3 trial (428 patients) met all prespecified endpoints.
The numbers (TRUTAKNA vs placebo):
- Mean eGFR change from baseline at 52 weeks: −0.1 vs −5.7 mL/min/1.73m² (treatment effect 5.6; 95% CI 3.7–7.5; p<0.0001) — i.e., true stabilization of kidney function
- Annualized eGFR slope through 104 weeks: −0.6 vs −5.6 mL/min/1.73m²/year (effect 5.0; p<0.0001) — meeting the KDIGO goal of slowing decline to the physiologic rate (<1 mL/min/1.73m²/year)
- Composite kidney disease progression through 104 weeks: 11 vs 38 events — hazard ratio 0.24, a 76% risk reduction (p<0.0001)
- Dialysis ≥30 days, transplant, or death: 0 vs 8 patients
- Safety generally comparable to placebo; no opportunistic infections or clinically relevant hypogammaglobulinemia
Dr. Richard Lafayette (Stanford, ORIGIN 3 principal investigator): "The ORIGIN 3 final analysis, demonstrating a significant reduction in risk of composite kidney disease progression, true stabilization of eGFR, and a favorable safety profile through two years, marks a milestone in IgAN treatment... We now have evidence suggesting that TRUTAKNA may help patients avoid dialysis, transplantation, or kidney-related death over the long term."
CEO Marshall Fordyce: "ORIGIN 3 is the first reported Phase 3 IgAN trial to reach alignment with the FDA on an earlier final efficacy analysis, offering patients randomized to placebo an earlier opportunity to transition to open-label TRUTAKNA. The final results support this alignment and we plan to submit the supplemental BLA in the fourth quarter of this year. We look forward to the potential full approval of TRUTAKNA in 2027."
Commercially, Vera reports over 350 patient start forms generated in the first ten weeks of launch, with paid claims and initial payer policies in place. The sBLA for full approval is planned for Q4 2026, with a potential FDA decision in 2027.