Vera Therapeutics received U.S. FDA accelerated approval for TRUTAKNA (atacicept-vymj) to reduce proteinuria in adults with primary IgA nephropathy at risk for disease progression. The ORIGIN 3 interim analysis reported a 46% reduction from baseline in proteinuria and a statistically significant 42% reduction versus placebo at 36 weeks. The therapy targets BAFF and APRIL, addressing upstream drivers of IgAN, and Vera said the regimen was generally well tolerated, with infections and local administration reactions among the most common adverse events. The approval gives a new mechanism option in a crowded kidney space where endpoints and speed-to-adoption can heavily influence uptake. Competition is expected to intensify as Vertex and others advance therapies aimed at the same cytokine axis for IgAN.
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