Novartis publishes the results of the mechanism study to support ligelizumab treatment CSU efficacy is better than Xolair!

Novartis recently published a mechanism study showing that ligelizumab (QGE03) is more effective in suppressing the main pathogenic IE/Fcri pathway for chronic spontaneous urticaria (CSU) than the company's listed drug Xolair (omalizumab, omazumab).

data show that Ligelizumab is 88 times more affinity than IgE.
in addition, there are differences between the identification and binding of IgE by ligelizumab and Xolair, and the conduction block of ligelizumab to IgE/Fc-RI signals is significantly enhanced.
this mechanism study is a major step forward in understanding how different anti-IgE therapies have different inhibitory properties, both qualitatively and functionally.
previously published IIb studies, a higher proportion of patients treated with ligelizumab had CSU symptoms completely eliminated than Xolair.
this mechanism study further supports these findings, suggesting that ligelizumab has the potential to reshape the treatment of CSU patients, and that the drug is expected to lead to a better treatment option for the CSU patient population.

. CSU is a skin disease characterized by urticaria, vascular edema, or both without specific external stimuli.
the disease is an unexplained recurrent-remission disease with a course of more than 6 weeks, and there is evidence that the disease is long-lasting and has a negative impact on quality of life.
Xolair, a monoclonal antibody drug targeted with IgE, was first approved in 2003 for the treatment of asthma patients with uncontrollable symptoms and again in 2014 for The DIA, which is difficult to treat with the H1 antihistamine drug.
Xolair was developed and promoted by Novartis in collaboration with Roche's Genetec.
in the first nine months of 2019, the drug generated sales of $870 million and $1.49 billion for Novartis and Roche, respectively.
in the United States and Europe, Xolair has lost patent protection and Novartis is actively promoting the clinical development of ligelizumab.
Ligelizumab is a new generation of induced anti-IgE monoclonal antibodies that block the IgE/SRI signaling pathway and have a higher IgE affinity than Xolair.
currently, ligelizumab is currently clinically developed in Stage III for use in Patients with CSU who cannot be adequately cured with H1 antihistamines.
Phase III of the drug includes two Phase III clinical studies (PEARL 1, PEARL 2) and has recruited more than 2,000 patients in 48 countries worldwide.
the two Phase III studies, which will be released later this year and completed by 2021, according to clinicaltrials.gov, the U.S. clinical trial database.
if all goes well, Novartis will submit a listing application for Ligelizumab by the end of 2021.
as a successor to Xolair, if Ligelizumab is successfully launched, it will help Novartis defend its CSU therapeutics franchise.
Reference source: Novartis reveals positives for Xolair follow-up.