Charlotte Robinson

DocwireNews

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&nbsp;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.&ldquo;Following the FDA&rsquo;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,&rdquo; said Uptal Patel, MD, chief medical officer at Human Immunology Biosciences, Inc., the drug&rsquo;s developer.&ldquo;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.&rdquo;

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FDA Grants Orphan Drug Designation to Felzartamab

Kidney Transplantation

The FDA granted Orphan Drug Designation for felzartamab to treat antibody-mediated rejection in kidney transplant recipients.

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