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Novartis' next-generation IgE antibody application for clinical application has received FDA breakthrough therapy designation

 Last Update: 2022-01-01
 Source: Internet
 Author: User

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Article source: Medical Rubik's Cube Info

Medicine Rubik's Cube Info

Author: Shi Bei

On December 2, the CDE official website showed that Novartis’ next-generation anti-immunoglobulin E (IgE) monoclonal antibody ligelizumab (QGE031) clinical application has been accepted by the State Food and Drug Administration

Ligelizumab is a next-generation anti-IgE monoclonal antibody developed by Novartis.

In January of this year, the FDA granted ligelizumab breakthrough therapy designation for the treatment of chronic spontaneous urticaria (CSU) that does not respond to H1-antihistamine therapy

In a phase IIb (NCT02477332) dose exploratory study of patients with moderate to severe CSU, compared with Novartis’s previous generation IgE antibody Xolair (omalizumab) group, more people in the ligelizumab group had complete remission of urticaria (51 % vs.

NCT02477332 study validity results

Two phase III clinical studies PEARL 1 and PEARL 2 of ligelizumab vs omalizumab for the treatment of CSU by Novartis are ongoing

CSU, also known as chronic idiopathic urticaria (CIU), is an unpredictable serious skin disease, and 0.

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