The FDA granted Vera Therapeutics accelerated approval for TRUTAKNA (atacicept-vymj) to reduce proteinuria in adults with primary IgA nephropathy at risk for disease progression. The decision is based on an interim analysis from the ongoing ORIGIN 3 trial. Vera reported a 46% reduction from baseline in proteinuria for TRUTAKNA, with a statistically significant 42% proteinuria reduction versus placebo at 36 weeks (p<0.0001). The company said the therapy was generally well tolerated, with infections and local administration reactions the most common adverse events. TRUTAKNA is positioned as a dual BAFF/APRIL inhibitor delivered once weekly by auto-injector, aiming to directly target upstream immune drivers in IgAN. The accelerated pathway requires confirmatory evidence on longer-term outcomes. The approval sets up intensifying competition in IgAN with Vertex Pharmaceuticals’ BAFF/APRIL program also under development in parallel, increasing pressure on timelines and confirmatory trial design for next-stage readouts.