FDA Grants Accelerated Approval to Atacicept for Primary IgA Nephropathy
The FDA has granted accelerated approval to atacicept (Trutakna) for reducing proteinuria in adults with primary IgA nephropathy at risk of disease progression. Supported by the ORIGIN 3 trial, the once-weekly self-administered therapy targets the BAFF and APRIL pathways, offering a novel treatment option to slow disease progression.
IgAN is a serious, progressive, immune-mediated kidney disease and a leading cause of chronic kidney disease and kidney failure worldwide.2,3 Approximately 160,000 patients are estimated to be impacted by IgAN in the U.S. Globally, approximately adults per 100,000 are diagnosed with IgAN each year, most often between 30 and 40 years of age.
“The approval of TRUTAKNA as the first and only BAFF and APRIL inhibitor for IgAN marks an important milestone and we believe it has the potential to meaningfully transform the treatment landscape.
We believe TRUTAKNA offers a novel approach to addressing this serious disease and has the potential to advance care for patients with this significant unmet medical need,” said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. “We are grateful to the patients, investigators, study teams and regulators whose efforts made this achievement possible.”
“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, M.D., F.A.C.P., 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.”
“We started the IgAN Foundation 22 years ago to create a community and encourage the development of innovative therapies. People and families living with this disease know how urgently we need more treatment options,” said Bonnie Schneider, Director and Co-Founder of the IgAN Foundation. “We value our long-standing relationship with Vera Therapeutics and our shared commitment to making the patient experience central to clinical research. The approval of TRUTAKNA provides great hope for patients and the IgAN community.”
This accelerated approval is based on reduction of proteinuria. It has not been established whether TRUTAKNA slows kidney function decline over the long-term in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the ongoing ORIGIN 3 trial, which continues in a placebo-controlled, blinded manner to evaluate change in kidney function as measured by estimated glomerular filtration rate (eGFR), with results anticipated in Q3 2026.
