Posted by Michael Wonder on 14 Jan 2021
Novartis ligelizumab (QGE031) receives FDA breakthrough therapy designation for patients with chronic spontaneous urticaria
14 January 2021 - Ligelizumab is the first treatment to receive FDA Breakthrough Therapy designation in chronic spontaneous urticaria in patients with an inadequate response to H1-anti-histamines.
Novartis today announced that the U.S. FDA has granted ligelizumab (QGE031) Breakthrough Therapy designation for the treatment of chronic spontaneous urticaria, also known as chronic idiopathic urticaria, in patients who have an inadequate response to H1-anti-histamine treatment.
Ligelizumab (QGE031) is a next generation monoclonal anti-immunoglobulin E antibody.
