Atacicept: First Approval

Atacicept (atacicept-vymj; TRUTAKNA^™) is a human recombinant fusion glycoprotein targeting B lymphocyte stimulator [BLyS; also known as B cell-activating factor (BAFF)] and A proliferation-inducing ligand (APRIL) being developed by Vera Therapeutics, under a license from Merck Serono. On 7 July 2026, atacicept received accelerated approval in the USA to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. In patients with IgAN, atacicept produced sustained reductions in proteinuria across the ORIGIN clinical development program and stabilized estimated glomerular filtration rates through 96 weeks. This article summarizes the milestones in the development of atacicept leading to this first approval for IgAN.