Pharma Focus Europe

HI-Bio Granted FDA Orphan Drug Designation for Felzartamab in Treating Antibody-Mediated Rejection in Kidney Transplant Recipients

Friday, March 22, 2024

Human Immunology Biosciences (HI-Bio™), a biotechnology company in the clinical stages of development, has recently announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for felzartamab. This designation is specifically for the treatment of antibody-mediated rejection (AMR) in kidney transplant recipients.

Dr. Uptal Patel, Chief Medical Officer at HI-Bio, expressed optimism about the recent developments, stating, "Following the FDA's granting of Breakthrough Therapy Designation for felzartamab in primary membranous nephropathy, we are encouraged by the Orphan Drug Designation for its use in treating antibody-mediated rejection. We anticipate presenting clinical data from our ongoing study of felzartamab in AMR at a medical conference this year. Our cellular depletion strategy targeting anti-CD38 has shown promise in various severe immune-mediated diseases, including AMR, IgA nephropathy, and primary membranous nephropathy."

The Orphan Drug Designation from the FDA is intended to facilitate the development of drugs for rare diseases or conditions affecting fewer than 200,000 individuals in the United States. HI-Bio now qualifies for certain development incentives, such as tax credits for qualified clinical trials, exemption from FDA application fees, and up to seven years of market exclusivity upon regulatory approval.

AMR is a significant contributor to kidney transplant failure, impacting around 23,000 patients in the U.S. late after transplantation. Current treatment options for AMR are limited, making the development of targeted therapies crucial. Felzartamab specifically targets CD38, a protein expressed on mature plasma cells, which play a role in the production of donor-specific antibodies linked to AMR.

HI-Bio is actively exploring the potential of felzartamab in various immune-mediated diseases, including IgA nephropathy, lupus nephritis, and primary membranous nephropathy. The company acquired the rights to felzartamab from MorphoSys in 2022 and holds exclusive worldwide rights for its development, excluding Greater China.



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