Vera's Trutakna (Atacicept) Wins FDA Accelerated Approval for IgA Nephropathy
On July 7, 2026, the FDA granted accelerated approval to Vera Therapeutics' Trutakna (atacicept-vymj), a recombinant fusion protein, to reduce proteinuria in adults with primary IgA nephropathy (IgAN) who are at risk of rapid disease progression. Trutakna is the first approved therapy in the U.S. that dual-inhibits both BAFF (B-cell activating factor) and APRIL (A proliferation-inducing ligand), two key cytokines that drive the production of the autoantibodies responsible for IgAN.
The approval is supported by 36-week interim data from the Phase 3 ORIGIN 3 trial, which demonstrated a statistically significant 42% reduction in the urinary protein-to-creatinine ratio (UPCR) compared to placebo.
Shifting Competitive Landscape and eGFR Milestones
Trutakna enters a highly crowded and competitive IgAN market as the sixth FDA-approved treatment. Unlike some earlier entrants, the FDA's label for Trutakna does not restrict eligibility based on baseline proteinuria levels.
To transition from accelerated to traditional, full approval, Vera must demonstrate a verified benefit on kidney function via changes in estimated glomerular filtration rate (eGFR). Vera recently aligned with the FDA to pull its eGFR analysis forward into Q3 2026 based on the strong effect size observed in its Phase 2b trial (which showed eGFR stabilization matching natural aging decline over 96 weeks).
- Otsuka's Voyxact (sibeprenlimab): An APRIL-only monoclonal antibody approved in late 2025. On July 1, 2026, Otsuka announced positive two-year Phase 3 Visionary trial results showing significant eGFR stabilization, intensifying the battle with Trutakna.
- Novartis' Fabhalta (iptacopan): A complement inhibitor currently under priority FDA review for traditional, full approval in IgAN.
- Vertex's Povetacicept: A rival BAFF/APRIL dual-inhibitor currently under Phase 3 development, with an FDA action date scheduled for November 30, 2026.
"Mechanistically, there are multiple places in IgAN pathogenesis to intervene, and Vera’s approach has been to intervene as far upstream as possible... What’s really important for value for patients in the field is durable eGFR stability over time. That’s what’s different about atacicept." — Dr. Marshall Fordyce, Founder and CEO of Vera Therapeutics