FDA Grants Accelerated Approval for Vera Therapeutics' Trutakna (Atacicept-Vymj) for Adult Patients with Primary IgA Nephropathy on Tuesday July 7: BAFF/APRIL-Targeting Fusion Protein Cut Proteinuria 45.7% Versus 6.8% for Standard of Care Alone at 36 Weeks in the ORIGIN Phase 3 Trial
The FDA granted accelerated approval Tuesday July 7, 2026 to Trutakna (atacicept-vymj) for adult patients with primary IgA nephropathy (IgAN) at risk of rapid disease progression, in combination with standard of care. Vera Therapeutics developed the drug as a recombinant fusion protein that combines the extracellular domain of the transmembrane activator and CAML interactor (TACI) receptor with the Fc portion of human IgG1, binding both B-cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL) to reduce autoantibody-driven kidney damage. The registrational Phase 3 ORIGIN trial data supporting approval: at 36 weeks, Trutakna plus standard of care produced a 45.7% reduction in urine protein-to-creatinine ratio versus a 6.8% reduction for standard of care alone. IgA nephropathy affects approximately 130,000 to 150,000 Americans and is the most common primary glomerular disease worldwide; approximately 40% of patients progress to end-stage renal disease within 20 years without adequate treatment. Trutakna is a fusion protein rather than a peptide but sits in adjacent therapeutic territory relevant to the site's peptide-and-biologic coverage. Vera Therapeutics (NASDAQ: VERA) is expected to launch the product in Q3 2026. Continued approval may be contingent on verification of clinical benefit in confirmatory Phase 3 studies.