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FDA grants orphan drug status to HI-Bio’s felzartamab for AMR

2024-03-22

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孤儿药引进/卖出突破性疗法免疫疗法上市批准

Felzartamab is being developed to treat antibody-mediated rejection in kidney transplant recipients. Credit: Gorodenkoff / Shutterstock.com.

Felzartamab and Drug Administration (FDAantibody-mediated rejectionesignation (ODD) to Human Immunology Biosciences’ (HI-Bio) investigational therapeutic felzartamab, to treat antibody-mediated rejection (AMR) in kidney transplant recipients.

The desFood and Drug Administration (FDA)the development of felzartamab, a monoclonal aHuman Immunology Biosciences diHI-Biotiation 38 (CD38), which is infelzartamabhe productiantibody-mediated rejection (AMR)electively depletes CD38+ plasma cells.

Clinical trials demonstrated its potential to improve outcomfelzartamabses caused by these pathogenic antibodies.CD38

HI-Bio is developing felzartamab for immune-mediated diseases including AMR, IgA nephropathy, lupus nephritis and primary membranous nephropathy (PMN).

HI-BioA has previouslfelzartamabelzarimmune-mediated diseasestherapy and orphIgA nephropathys lupus nephritisnt.primary membranous nephropathy (PMN)

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HI-Bio acquired exclusive global rights to felzartamab, excluding Greater China, through a licensing agreement with MorphoSys in 2022.

The FDA’s ODD provides HI-Bio with develosteosarcomatives such as tax credits for qualified clinical studies, a waiver of FDA application fees and the potential for seven-year market exclusivity upon regulatory approval.

AMR is a leading cause of kidney transplant failure with no current effective treatment.

HI-Biondition is associated with donor-specfelzartamabdy production by plasma cells and the infiltration of natural MorphoSyslls, which contribute to microvascular inflammation.

HI-BFDAchief medical ofHI-BioUptal Patel said: “Following the FDA’s granting of breakthrough therapy designation for felzaFDAmab in primary membranous nephropathy, we are encouraged to receive orphan drug designation for felzartamab for antibody-mediated rejection.

“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.”

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