FDA Grants Orphan Drug Designation to Felzartamab

The US Food and Drug Administration (FDA) granted Orphan Drug Designation for felzartamab to treat antibody-mediated rejection (AMR) in kidney transplant recipients.

Donor-specific antibody (DSA) production by plasma cells and tissue infiltration of natural killer (NK) cells presumed to be involved in DSA-dependent microvascular inflammation are linked to AMR. Both plasma cells and NK cells express high levels of the protein CD38; felzartamab is a human monoclonal antibody that targets CD38 to deplete these cell populations. Felzartamab may have applications in many diseases driven by pathogenic antibodies.

“Following the FDA’s granting of Breakthrough Therapy Designation for felzartamab in primary membranous nephropathy, we are encouraged to receive Orphan Drug Designation for felzartamab for antibody-mediated rejection,” said Uptal Patel, MD, chief medical officer at Human Immunology Biosciences, Inc., the drug’s developer.

“Along with our academic collaborators, we look forward to submitting clinical data from the ongoing study of felzartamab in antibody-mediated rejection to a medical conference this year. We are confident in the clinical progress of our anti-CD38 cellular depletion strategy, which to date, has resulted in proof-of-concept data in multiple severe immune-mediated diseases including antibody-mediated rejection, IgA nephropathy, and primary membranous nephropathy.”