Biotechnology company Biogen Inc (Nasdaq:BIIB) on Wednesday announced that felzartamab, an investigational anti-CD38 monoclonal antibody, has received Breakthrough Therapy Designation (BTD) from the US Food and Drug Administration (FDA) for the treatment of late antibody-mediated rejection (AMR) in kidney transplant patients.

This designation is intended to expedite the development and review of felzartamab, which has shown promising results in clinical trials.

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.