Vera Therapeutics Submits BLA For Atacicept In IgA Nephropathy

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(RTTNews) - Vera Therapeutics Inc. (VERA) announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for atacicept, its investigational therapy for adults with immunoglobulin A nephropathy (IgAN). The application was submitted under the FDA's Accelerated Approval Program, which is designed to expedite the availability of treatments for serious conditions that fill an unmet medical need.

IgAN is a serious and progressive autoimmune disease of the kidney, for which there remains a high unmet need for new disease-modifying treatments that target the upstream source of the disease. In at least 50% of patients, IgAN can lead to end-stage kidney disease or kidney failure, which has onsiderable morbidity and impact on patients lives. Atacicept is being developed as an at-home self-administered subcutaneous once-weekly injection that inhibits 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.

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