FDA grants breakthrough therapy designation to felzartamab
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Key takeaways:
- Felzartamab is an investigational, therapeutic human monoclonal antibody that targets CD38, a protein expressed on mature plasma cells.
- Study results will be presented at the American Society of Nephrology Kidney Week in Philadelphia.
The FDA has granted breakthrough therapy designation for felzartamab, an investigational antibody to treat primary membranous nephropathy.
The designation expedites development and review of drugs intended to treat serious conditions, according to a press release from biotech company Human Immunology Biosciences Inc. (HI-Bio).
“The FDA’s decision to grant breakthrough therapy designation is recognition of the promising data we have collected, as well as an acknowledgement of the need for major advances over available therapies in the treatment of patients with [primary membranous nephropathy] PMN,” Uptal Patel, MD, chief medical officer of HI-Bio, said in the release.
The labeling comes after results of M-PLACE, a phase 1b/2a proof-of-concept, open-label study, were shown to the FDA. Results of the M-PLACE study are scheduled to be presented by Brad Rovin, MD, director of the nephrology division at The Ohio State University, at the American Society of Nephrology Kidney Week in Philadelphia.
Felzartamab (HI-Bio) is a therapeutic human monoclonal antibody that targets CD38, a protein expressed on mature plasma cells, according to the release. HI-Bio in-licensed felzartamab from MorphoSys in June 2022, with exclusive worldwide rights excluding Greater China.
In addition to the increased FDA attention felzartamab will garner, the designation also comes with eligibility for more regulatory interaction, and potential accelerated approval, priority review and rolling review of a biologics license application.
“We believe that the cellular depletion strategy with felzartamab in PMN is applicable to many more immune-mediated diseases driven by antibodies produced in CD38[-positive] plasma cells,” Patel said in the release. “We are currently developing felzartamab in multiple diseases including PMN, IgA nephropathy, antibody-mediated rejection and lupus nephritis."
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 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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