The approval enables to use of ligelizumab to treat CSU, also called chronic idiopathic urticaria (CIU), in patients who have an inadequate response to H1-antihistamine treatment.
CSU is an unpredictable and severe disease of the skin, which is said to affect 0.5-1% of the global population at any time.
Ligelizumab, a next-generation monoclonal anti-immunoglobulin E (IgE) antibody, is believed to work by restricting the IgE/FcεRI pathway, a crucial driver of the inflammatory process in CSU.
More patients experienced complete resolution of wheals (hives) with ligelizumab compared with Xolair (omalizumab) in a phase IIb dose-finding trial, said the company.
At present, Ligelizumab compared with omalizumab is being assessed in ongoing phase III clinical trial programmes including PEARL 1 and PEARL 2.
The clinical studies have enrolled over 2,000 patients in 48 countries across the globe. The results are expected to be revealed in the second half of 2021.
Novartis immunology, hepatology and dermatology unit development unit global head Dr Angelika Jahreis said: “Chronic spontaneous urticaria is a debilitating disease that may significantly impact a patient’s life. With so few treatment options available, patients are looking for more and better therapies to control their disease.
“The FDA breakthrough therapy designation recognises the need for a more effective treatment for this unpredictable, systemic and debilitating disease.”
In December 2020, Novartis agreed to acquire US-based neuroscience company Cadent Therapeutics for a total potential consideration of $770m.
Based in Cambridge of Massachusetts, Cadent Therapeutics is involved in the development of therapies to treat cognitive, mood, and movement disorders.