Biogen Breamthrough Tag for Treatment of Antibody-Mediated Rejection in Kidney Transplant

 

• Designation is based on data from the clinical development program which demonstrated clinical proof of concept
  
• Felzartamab, an investigational anti-CD38 monoclonal antibody, is a potential first-in-class therapeutic candidate for a range of rare immune-mediated indications with planning underway for Phase 3 development
• FDA Breakthrough Therapy Designation is intended to expedite the development and review of drugs for serious or life-threatening conditions and which have potential to show substantial improvement over existing therapies

https://www.globenewswire.com/news-release/2024/10/09/2960415/0/en/Biogen-Receives-U-S-FDA-Breakthrough-Therapy-Designation-for-Felzartamab-for-the-Treatment-of-Antibody-Mediated-Rejection-in-Kidney-Transplant-Recipients.html