The FDA approved Vera Therapeutics’ Trutakna (atacicept) for IgA nephropathy (IgAN), giving the biotech an accelerated approval for adults with primary IgAN at risk for disease progression. The company is positioning Trutakna as a once-weekly, auto-injector therapy aimed at reducing proteinuria. Regulators cleared the drug on its July 7 PDUFA date and the approval marks the first dual BAFF/APRIL inhibitor for IgAN. A confirmatory trial, Origin 3, is already underway, with results expected in the third quarter and potential full approval targeted for 2027. The approval also sets up competitive timing in the IgAN market, including Vertex’s broader nephrology portfolio and ongoing development strategies across glomerular disease.
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