Biogen Receives U.S. FDA Breakthrough Therapy Designation for Felzartamab for the Treatment of Antibody-Mediated Rejection in Kidney Transplant Recipients

Biogen Inc. announced today that felzartamab, an investigational anti-CD38 monoclonal antibody, has received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) for the treatment of late antibody-mediated rejection (AMR) without T-cell mediated rejection in kidney transplant patients.

The FDA grants BTD to drug candidates for serious or life-threatening conditions and that have preliminary clinical evidence demonstrating potential to provide substantial improvement over existing therapies. The designation provides additional opportunities to engage the FDA and to support the drug development program through Fast Track designation features.

Designation is based on data from the clinical development program which demonstrated clinical proof of concept. Felzartamab, an investigational anti-CD38 monoclonal antibody, is a potential first-in-class therapeutic candidate for a range of rare immune-mediated indications with planning underway for Phase 3 development.

Data from the clinical development program that supported the designation were published in the New England Journal of Medicine and presented as a late-breaking presentation at the 61st European Renal Association (ERA) Congress in Stockholm, May 2024.

Felzartamab previously received BTD and Orphan Drug Designation (ODD) from the FDA for development in the treatment of primary membranous nephropathy (PMN) and ODD in the treatment of AMR in kidney transplant recipients. Phase 2 studies have been completed in AMR, PMN and IgA nephropathy (IgAN). Biogen plans to initiate Phase 3 trials for felzartamab across AMR, IgAN, and PMN in 2025.