Vera Therapeutics won accelerated FDA approval for TRUTAKNA (atacicept-vymj) to reduce proteinuria in adults with primary IgA nephropathy at risk for disease progression. The approval is based on an interim analysis from the ongoing ORIGIN 3 trial. Vera reported a 46% reduction from baseline in proteinuria in the treated group, with a 42% reduction versus placebo at 36 weeks and a p-value reported as highly significant. The therapy is designed to inhibit both BAFF and APRIL, targeting upstream immunological drivers of IgA nephropathy. The company highlighted a tolerability profile where infections and local administration reactions were among the most common adverse events. With Vertex expected to deliver a regulatory decision later in the year on a competitive dual-target concept, Vera’s fast-track milestone intensifies the race for early-stage kidney disease disease-modifying therapies.
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