The FDA has granted accelerated approval to atacicept-vymj (Trutakna) for reducing proteinuria in adults with primary IgA nephropathy at risk of disease progression. It's the first approved drug to target both BAFF and APRIL — two key cytokines driving the disease. This brings the total number of approved therapies for IgA nephropathy in the U.S. to six, all within the past five years.
The FDA has granted accelerated approval to atacicept-vymj (Trutakna, Vera Therapeutics) for proteinuria reduction in adults with primary IgA nephropathy (IgAN) at risk for disease progression. What makes it stand out: it's the first approved therapy to simultaneously target both BAFF and APRIL — the two key cytokines that drive B-cell activity at the root of IgAN pathophysiology.
Approval was based on a prespecified interim analysis from the ORIGIN 3 clinical trial, with data published in the New England Journal of Medicine in 2025. Patients on weekly 150 mg injections of atacicept-vymj saw meaningful reductions across multiple disease markers compared to placebo, with a generally mild-to-moderate safety profile.
By the Numbers:
Why it matters: Trutakna's approval brings the total number of U.S.-approved therapies for IgAN to six — all within the last five years — signaling a rapidly maturing treatment landscape for a disease that historically carried a high risk of poor outcomes. Full approval will hinge on 2-year eGFR data.
