Research & Development
Human Immunology Biosciences receives ODD from FDA for felzartamab
22 March 2024 -

Human Immunology Biosciences (HI-Bio), a clinical-stage biotechnology company, announced on Thursday that it has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for its felzartamab.

The product is intended to treat antibody-mediated rejection (AMR) in kidney transplant recipients.

Orphan Drug Designation allows the company 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.

The product is an investigational therapeutic human monoclonal antibody aimed at CD38, a protein expressed on mature plasma cells.