The FDA cleared Vera Therapeutics’ Trutakna (atacicept) as the first dual BAFF/APRIL inhibitor for immunoglobulin A nephropathy (IgAN), marking a new accelerated-approval milestone in kidney autoimmunity. The nod was granted for reducing proteinuria in adults with primary IgAN at risk for disease progression, with Trutakna dosed once weekly via auto-injector. Regulators tied the decision to proteinuria reduction, and the development path now centers on long-term clinical verification. Vera’s confirmatory Origin 3 trial is already underway, with results expected in the third quarter and a potential full-approval timeline extending into 2027. The clearance also sets up competitive timing against Vertex, which is pursuing its own approach in proteinuric glomerular disease, as Vera looks to establish early clinical and prescribing momentum for a weekly at-home administered therapy.
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