On October 9, 2024, Biogen Inc. announced that felzartamab, an investigational anti-CD38 monoclonal antibody, received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA). This designation is for the treatment of late antibody-mediated rejection (AMR) without T-cell mediated rejection in kidney transplant patients, a condition representing a significant unmet medical need.
The FDA grants BTD to drug candidates for serious or life-threatening conditions that demonstrate preliminary clinical evidence of potential substantial improvement over available therapies. This designation provides additional opportunities for engagement with the FDA and supports the drug development program through Fast Track designation features, aiming to accelerate its path to market.
Data supporting this designation were published in the New England Journal of Medicine and presented at the 61st European Renal Association (ERA) Congress in May 2024. Felzartamab, a key asset from Biogen's July 2024 acquisition of Human Immunology Biosciences (HI-Bio), had previously received BTD and Orphan Drug Designation for primary membranous nephropathy (PMN) and Orphan Drug Designation for AMR. Biogen plans to initiate Phase 3 trials for felzartamab across AMR, IgA nephropathy (IgAN), and PMN in 2025.
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