The FDA granted accelerated approval to Vera Therapeutics’ Trutakna (atacicept-vymj) for adults with primary IgA nephropathy (IgAN) at risk for progression, according to the company. Trutakna is described as the first dual BAFF and APRIL inhibitor in the indication and is delivered once weekly via an auto-injector. In a prespecified interim analysis from the ongoing ORIGIN 3 trial, Trutakna achieved a 46% reduction from baseline in proteinuria, with a 42% clinically meaningful reduction versus placebo at 36 weeks (p<0.0001). The most common adverse reactions were infections and local administration reactions. Vera framed the approval as a milestone for an immunological driver of IgAN where current therapies can fail to prevent disease progression. The company also indicated a confirmatory path is underway to support longer-term outcomes beyond proteinuria reduction.