53 LR Ligelizumab, a high-affinity anti-IgE antibody, demonstrated superiority compared with... December 20, 2021 01:15 ET | Source: … The new treatment is being studied in chronic spontaneous urticaria (CSU), one of Xolair’s approved indications . Novartis Pharma AG: Novartis provides an update on Phase III ... Basel, January 14, 2021 — Novartis today announced that the U.S. Food and Drug Administration (FDA) has granted ligelizumab (QGE031) Breakthrough Therapy designation for the treatment of chronic spontaneous urticaria (CSU), also known as chronic idiopathic urticaria (CIU), in patients who have an inadequate response to H1-antihistamine treatment. Novartis ligelizumab (QGE031) receives FDA Breakthrough … Ligelizumab (INN; development code QGE031) is a humanized IgG1 monoclonal antibody designed for the treatment of severe asthma and chronic spontaneous urticaria. Antibodies with Advanced Verification … Basel, January 14, 2021 — Novartis today announced that the U.S. Food and Drug Administration (FDA) has granted ligelizumab (QGE031) Breakthrough Therapy designation for … Overview. 1 Trial of Omalizumab Biosimilar, CT-P39 Ligelizumab Launch