 Home > Medical News > Latest Medical News > Novartis' next-generation IgE antibody application for clinical application has received FDA breakthrough therapy designation

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

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

Tags

phase control

1 2 dimethoxyethane

Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com

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.

This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

Related Products

L-Ascorbate-2-Monophosphate Feed Grade

CAS No.: 109620-90-8

Feed Grade

Potassium Sorbate from reliable manufacturer

CAS No.: 590-00-1

Food Grade

Doxycycline Hydrochloride

CAS No.: 10592-13-9

Pharmaceutical Grade

Hot Tags

united states jobs(223)

jobs united states(236)

1 year treasury(277)

1 year subscription(296)

announcements today(81)

80 20 company(94)

united states logo(227)

single use technology(195)

healthy food name(42)

ups united states(221)

Hot Articles

The source of this page with content of products and services is from Internet, which doesn't represent ECHEMI's opinion. If you have any queries, please write to service@echemi.com. It will be replied within 5 days.

Moreover, if you find any instances of plagiarism from the page, please send email to service@echemi.com with relevant evidence.