On November 7, Vera Therapeutics announced that it submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) through the Accelerated Approval Program for atacicept for the treatment of adults with immunoglobulin A nephropathy (IgAN), a progressive autoimmune disease of the kidney. According to the press release, atacicept is a recombinant fusion protein that contains the soluble transmembrane activator and calcium-modulating cyclophilin ligand interactor (TACI) receptor that binds to the cytokines B-cell activating factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL), cytokines that drive B-cell production of autoantibodies associated with IgAN and potentially other autoimmune kidney diseases.
Based on FDA’s assessment of data from the ORIGIN phase 2b clinical trial, atacicept has received FDA Breakthrough Therapy Designation for the treatment of IgAN, as atacicept may demonstrate substantial improvement on a clinically significant endpoint over available therapies for patients with IgAN. Atacicept is being developed as an at-home self-administered subcutaneous once-weekly injection.
According to Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics, this is the first BLA submission by Vera Therapeutics.