Vera Therapeutics received FDA accelerated approval for TRUTAKNA (atacicept-vymj) to treat adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. The decision follows an interim analysis of the ORIGIN 3 trial showing proteinuria reductions versus placebo. In the prespecified interim readout at 36 weeks, TRUTAKNA achieved a 46% reduction in proteinuria from baseline and a statistically significant 42% reduction compared with placebo. The safety profile was described as generally well tolerated, with infections and local administration reactions among the most common adverse events. The approval marks a first-in-class positioning for blocking both BAFF and APRIL, setting up competitive expectations for earlier-line use and encouraging additional late-stage confirmatory work in the IgAN space.
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