The U.S. FDA granted accelerated approval to Vera Therapeutics’ Trutakna (atacicept) to reduce proteinuria in adults with primary IgA nephropathy (IgAN) at risk for disease progression. The decision is based on a prespecified interim analysis from the ongoing ORIGIN 3 trial, where Trutakna achieved a 46% reduction from baseline in proteinuria and a 42% reduction versus placebo at 36 weeks (p<0.0001). Trutakna is the first therapy designed to bind both B-cell activating factor (BAFF) and APRIL, targeting the immunological drivers at the source of IgAN. It is administered subcutaneously once weekly via auto-injector, with common adverse reactions including infections and local administration reactions. Vera positioned the approval as a potential shift in IgAN treatment, with a confirmatory ORIGIN 3 program already underway and long-term outcomes to be assessed via estimated GFR decline. Competition in IgAN treatment is expected to intensify as the next phase of results approaches.