Human Immunology Biosciences (HI-Bio™) today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for felzartamab for the treatment of antibody-mediated rejection (AMR) in kidney transplant recipients.
| SOUTH SAN FRANCISCO, Calif., March 21, 2024 /PRNewswire/ -- Human Immunology Biosciences (HI-Bio™), a clinical-stage biotechnology company developing targeted therapies for patients with severe immune-mediated diseases (IMDs), today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for felzartamab for the treatment of antibody-mediated rejection (AMR) in kidney transplant recipients.
“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, M.D., Chief Medical Officer at HI-Bio. “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.” The FDA’s Orphan Drug Designation program is designed to advance the development of drugs and biologics intended to treat a rare disease or condition that affects fewer than 200,000 people in the United States. Orphan Drug Designation qualifies HI-Bio for certain development incentives, including tax credits for qualified clinical trials, exemption of FDA application fees and up to seven-year market exclusivity upon regulatory approval. About Antibody-Mediated Rejection (AMR) in Kidney Transplant Recipients About Felzartamab HI-Bio is focused on developing felzartamab in a number of immune-mediated diseases, including antibody-mediated rejection (AMR), IgA nephropathy (IgAN), lupus nephritis (LN) and primary membranous nephropathy (PMN). Felzartamab has received Breakthrough Therapy designation and Orphan Drug Designation from the FDA for development in the treatment of PMN, and Orphan Drug Designation in the treatment of AMR in kidney transplant recipients. HI-Bio in-licensed felzartamab from MorphoSys in 2022 and holds exclusive worldwide rights for felzartamab with the exception of Greater China. Felzartamab is an investigational therapeutic candidate that has not yet been approved by any regulatory authority. About HI-Bio
SOURCE HI-Bio | ||||||
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