The designation is a significant step in the development of felzartamab, a monoclonal antibody targeting cluster of differentiation 38 (CD38), which is involved in the production of pathogenic antibodies. It selectively depletes CD38+ plasma cells.
Clinical trials demonstrated its potential to improve outcomes in diseases caused by these pathogenic antibodies.
The FDA has previously awarded felzartamab both breakthrough therapy and orphan drug statuses for PMN treatment.
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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 development incentives 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.
The condition is associated with donor-specific antibody production by plasma cells and the infiltration of natural killer cells, which contribute to microvascular inflammation.
HI-Bio chief medical officer Uptal Patel said: “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.