Novartis Submits Clinical Application for Next-Gen Anti-IgE Antibody Ligelizumab, Granted FDA Breakthrough Therapy Designation

Source of the article:PharmaCube Info

Author: Shi Bei

On December 2, the CDE website showed that the clinical application of Novartis' next-generation anti-immunoglobulin E (IgE) monoclonal antibody ligelizumab (QGE031) has been accepted by the National Medical Products Administration.

Ligelizumab is a next-generation anti-IgE monoclonal antibody developed by Novartis. It works by blocking the IgE/FcεRI pathway, which is a key driver of the inflammatory process in CSU. The product is currently in Phase III clinical trials abroad for the treatment of chronic spontaneous/induced urticaria and peanut allergy.

In January this year, the FDA granted ligelizumab Breakthrough Therapy designation for the treatment of chronic spontaneous urticaria (CSU) with inadequate response to H1-antihistamine therapy.

In a Phase IIb (NCT02477332) dose-finding study conducted in patients with moderate to severe CSU, a higher proportion of patients achieved complete resolution of urticaria in the ligelizumab group compared to the Xolair (omalizumab) group, Novartis' previous generation IgE antibody (51% vs. 26%). No safety issues were identified with ligelizumab when compared to omalizumab or placebo.

NCT02477332 Study Efficacy Results

Novartis' two Phase III clinical studies, PEARL 1 and PEARL 2, comparing ligelizumab with omalizumab for the treatment of CSU, are currently underway. These two clinical studies have recruited over 2,000 patients across 48 countries worldwide, with results expected to be announced in the second half of 2021.

CSU, also known as Chronic Idiopathic Urticaria (CIU), is an unpredictable and severe skin condition that affects 0.5-1% of the global population. It is characterized by itchy, painful wheals (hives), swelling (angioedema), and hives may occur with angioedema simultaneously. Symptoms persist for at least 6 weeks, and the cause is unknown. Due to its severity and unpredictability, CSU often presents challenges and suffering for patients. The condition typically lasts 1-5 years, and in some cases, even longer.