FDA approves Trutakna for primary IgA nephropathy

FDA has granted accelerated approval to Trutakna (atacicept-vymj) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression. The approval adds a new targeted treatment option for a disease in which persistent proteinuria is a major predictor of progressive kidney function loss.

Trutakna is the first approved therapy to inhibit both B-cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL), reducing production of the abnormal IgA antibodies that contribute to kidney injury. The once-weekly subcutaneous injection is intended for use in addition to optimized supportive care.

Approval was based on an interim analysis of the phase 3 ORIGIN trial. At nine months, patients treated with Trutakna achieved a 46% reduction in proteinuria from baseline compared with a 7% reduction with placebo. Continued approval will depend on confirmation that treatment slows long-term loss of kidney function.

The most common adverse reactions were upper respiratory tract infection, nasopharyngitis, and headache. Because Trutakna suppresses the immune system, clinicians should evaluate patients for active infection before treatment and avoid live vaccines during therapy.

"I frequently hear from IgAN patients who are uncertain about what this disease may mean for their future, reflecting the historic high risk of poor outcomes with standard therapies," said Richard Lafayette, MD, FACP, Professor of Medicine, Nephrology, and Director of the Glomerular Disease Center at Stanford University Medical Center and a principal investigator in the ORIGIN clinical program. “Trutakna offers patients and their nephrologists an exciting new treatment advancement that inhibits both BAFF and APRIL, the two key cytokines that act on B cells, which are at the source of IgAN pathophysiology.”

Sources: Food & Drug Administration. (2026, July 7). FDA Approves New Treatment to Reduce Proteinuria in Adults with Primary Immunoglobulin A Nephropathy; Vera Therapeutics. (2026, July 7). FDA Accelerated Approval of Trutakna for Adult Patients with Primary IgA Nephropathy