FDA grants orphan drug status to HI-Bio’s felzartamab for AMR
22 Mar 2024
Orphan DrugLicense out/inBreakthrough TherapyImmunotherapyDrug Approval
Preview
Source: Pharmaceutical Technology
Felzartamab is being developed to treat antibody-mediated rejection in kidney transplant recipients. Credit: Gorodenkoff / Shutterstock.com.
The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to Human Immunology Biosciences’ (HI-Bio) investigational therapeutic felzartamab, to treat antibody-mediated rejection (AMR) in kidney transplant recipients.
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.
HI-Bio is developing felzartamab for immune-mediated diseases including AMR, IgA nephropathy, lupus nephritis and primary membranous nephropathy (PMN).
The FDA has previously awarded felzartamab both breakthrough therapy and orphan drug statuses for PMN treatment.
See Also:
Italfarmaco secures FDA approval for Duchenne muscular dystrophy drug
Preview
Source: Pharmaceutical Technology
Lisata clinches rare disease status for osteosarcoma drug
Preview
Source: Pharmaceutical Technology
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.
“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.”
For more details,please visit the original website
The content of the article does not represent any opinions of Synapse and its affiliated companies. If there is any copyright infringement or error, please contact us, and we will deal with it within 24 hours.
Targets
Drugs
Hot reports
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.