Biogen’s Felzartamab Gains the US FDA’s Breakthrough Therapy Designation to Treat AMR in Kidney Transplant Recipients
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- The US FDA has granted BTD to Felzartamab for treating late antibody-mediated rejection (AMR) without T-cell mediated rejection in kidney transplant individuals. The company anticipates a P-III study for felzartamab across AMR, IgAN, and PMN in 2025.
- BTD approval was based on the data from the clinical development program that validated clinical proof of concept. This data was published in the NEJM and presented as a late-breaking presentation at the 61st ERA Congress in Stockholm, in May 2024.
- Felzartamab is a human mAb under investigation that targets CD38, a protein shown in mature plasma cells, and P-II trials for Felzartamab have been completed in AMR, PMN, and IgAN. HI-Bio holds exclusive development & commercial rights of felzartamab across all indications globally excluding China; in July 2024 Biogen acquired HI-Bio
Ref: Biogen | Image: Biogen
Related News: HI-Bio Presents Positive Interim Data from P-II (IGNAZ) Trial of Felzartamab for IgAN at 61st ERA Congress 2024
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A passionate content writer with expertise in delivering high-quality and engaging content, Dipanshu is a keen reader and a versatile writer. Dipanshu dedicatedly covers news ranging from biopharma, life sciences, biotech, and MedTech to diagnostics and animal health companies. He can be contacted at connect@pharmashots.com
