What's Happening?
Vera Therapeutics, a biotechnology company, has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for atacicept, a treatment for immunoglobulin A nephropathy (IgAN). This submission is part of the FDA's Accelerated
Approval Program. Atacicept is a recombinant fusion protein that targets B-cell activating factor (BAFF) and A Proliferation-Inducing Ligand (APRIL), which are involved in the survival of B-cells and production of autoantibodies linked to IgAN. The application is supported by data from the ORIGIN Phase 3 trial, which showed a significant reduction in proteinuria, a key marker of kidney disease, in patients treated with atacicept compared to placebo. The trial's interim results were presented at the American Society of Nephrology Kidney Week and published in the New England Journal of Medicine.
Why It's Important?
The submission of atacicept for FDA approval is significant as it could lead to the first B-cell modulator targeting both BAFF and APRIL for IgAN, a serious autoimmune kidney disease. IgAN can lead to end-stage kidney disease in many patients, highlighting the need for new treatments. If approved, atacicept could change the standard of care for IgAN, providing a new option for patients who currently have limited treatment choices. The potential approval of atacicept also represents a milestone for Vera Therapeutics, positioning the company as a leader in developing treatments for autoimmune kidney diseases.
What's Next?
The FDA will review the BLA submission for atacicept, with a potential approval expected in 2026. Vera Therapeutics will continue to work with regulatory authorities to advance the approval process. The ongoing ORIGIN 3 trial will continue to evaluate the long-term effects of atacicept on kidney function, with results expected in 2027. Vera Therapeutics is also exploring the use of atacicept in other autoimmune kidney diseases, which could expand its therapeutic applications.
