The FDA granted accelerated approval to Vera Therapeutics’ Trutakna (atacicept) for immunoglobulin A nephropathy (IgAN), clearing a weekly, auto-injector therapy as the first dual BAFF/APRIL inhibitor in the indication. The approval was issued on the July 7 PDUFA date and is based on reductions in proteinuria in adults with primary IgAN at risk for progression. Vera said a confirmatory study, Origin 3, is already underway, with results expected in the third quarter. Regulators will assess long-term clinical benefit using endpoints including estimated glomerular filtration rate (eGFR) decline, given proteinuria was used for accelerated approval. The decision sets up competitive pressure in IgAN by giving Vera an earlier regulatory head start versus Vertex’s pipeline, while also increasing scrutiny of durability for dual BAFF/APRIL pathway inhibition.