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Biogen Highlights the Potential of Felzartamab for a Range of Immune-Mediated Diseases Including Three Phase 3 Programs in Rare Kidney Diseases
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Biogen is making a significant strategic pivot into immunology and rare diseases with felzartamab, an investigational anti-CD38 monoclonal antibody. This promising drug is designed to precisely target and deplete autoantibody-producing cells, offering potential for a broad range of immune-mediated conditions. Biogen is backing felzartamab with the initiation of three pivotal Phase 3 studies in 2025 for critical rare kidney diseases: late antibody-mediated rejection (AMR) in kidney transplant patients, Immunoglobulin A nephropathy (IgAN), and primary membranous nephropathy (PMN). These studies follow compelling positive results from earlier Phase 2 trials, demonstrating felzartamab's potential. The company anticipates the first readouts by 2027, with felzartamab already having received Breakthrough Therapy and Orphan Drug Designations from regulatory bodies in both the US and Europe, highlighting the significant unmet need and its therapeutic promise in these life-threatening conditions.