FDA grants orphan drug designation to felzartamab
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Key takeaways:
- The designation is designed to further develop drugs for serious conditions and biologics.
- Felzartamab received breakthrough therapy designation labeling from the FDA in 2023.
The FDA has granted orphan drug designation for felzartamab, an antibody-mediated rejection therapy for kidney transplant recipients, according to a press release.
The designation is designed to further develop drugs for serious conditions and biologics, as well as rare diseases or illnesses that affect fewer than 200,000 U.S. adults, biotech company Human Immunology Biosciences Inc. (HI-Bio) noted in the release. The tag also qualifies HI-Bio for development incentives such as clinical trial tax credits, FDA application fee waivers and up to 7-year market exclusivity after regulatory approval.
“We are encouraged to receive orphan drug designation for felzartamab,” Uptal Patel, MD, chief medical officer at HI-Bio, said in the release. “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.”
Felzartamab received breakthrough therapy designation labeling from the FDA in 2023 following results of M-PLACE, a phase 1b/2a proof-of-concept, open-label study. The therapeutic human monoclonal antibody targets CD38, a protein expressed on mature plasma cells, according to HI-Bio. The company in-licensed felzartamab from MorphoSys in June 2022, with exclusive worldwide rights excluding Greater China.
“We are confident in the clinical progress of our anti-CD38 cellular depletion strategy,” Patel said, which “has resulted in proof-of-concept data in multiple severe immune-mediated diseases including antibody-mediated rejection, IgA nephropathy and primary membranous nephropathy.”
References:
- HI-Bio announces felzartamab granted breakthrough therapy designation by U.S. Food and Drug Administration for primary membranous nephropathy (PMN). https://hibio.com/news/hi-bio-announces-felzartamab-granted-breakthrough-therapy-designation-by-u-s-food-and-drug-administration-for-primary-membranous-nephropathy-pmn. Published Oct. 31, 2023. Accessed Nov. 1, 2023.
- HI-Bio receives FDA orphan drug designation for felzartamab for the treatment of antibody-mediated rejection (AMR) in kidney transplant recipients. https://hibio.com/news/hi-bio-receives-fda-orphan-drug-designation-for-felzartamab-for-the-treatment-of-antibody-mediated-rejection-amr-in-kidney-transplant-recipients. Published Mar. 21, 2024. Accessed Mar. 22, 2024.
- HI-Bio to present at the American Society of Nephrology Kidney Week 2023 Annual Meeting. https://hibio.com/news/hi-bio-to-present-at-the-american-society-of-nephrology-kidney-week-2023-annual-meeting. Published Oct. 13, 2023. Accessed Nov. 1, 2023.
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