Novartis ligelizumab (QGE031) receives FDA Breakthrough Therapy designation for patients with chronic spontaneous urticaria (CSU)

  • Ligelizumab is the first treatment to receive FDA Breakthrough Therapy designation in chronic spontaneous urticaria (CSU) in patients with an inadequate response to H1-antihistamines1
     
  • Currently there are limited approved therapies for patients with CSU, also known as chronic idiopathic urticaria (CIU)
     
  • Breakthrough Therapy designation suggests ligelizumab has the potential to provide a substantial benefit over existing available treatments
     
  • U.S. regulatory filing in CSU is anticipated in 2022 …
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