December 20, 2021: “Novartis announced top-line results from PEARL 1 and PEARL 2 Phase III studies in chronic spontaneous urticaria (CSU), which showed that the studies met their primary endpoints of superiority for ligelizumab versus placebo at Week 12, but not versus omalizumab.
“We are disappointed that we have been unable to demonstrate superior efficacy for ligelizumab versus standard of care in the treatment of CSU,” said John Tsai, M.D., Head of Global Drug Development and Chief Medical Officer, Novartis.
“We will continue to evaluate the potential for ligelizumab to bring benefit to patients in the areas of chronic inducible urticaria (CIndU) and food allergy, where there is significant unmet need.”
Full PEARL 1 and 2 Phase III data will be made publicly available after study completion in the second half of 2022.
CSU is an unpredictable, systemic skin disease, characterized by the spontaneous and recurrent appearance of itchy, painful hives (wheals) on the skin, angioedema or both for at least 6 weeks and affects up to 1% of the population at any one time.
Approximately 60% of patients do not achieve complete control with first-line treatment antihistamines.
Novartis recently began Phase III studies for remibrutinib (LOU064), a highly selective, potent oral BTK inhibitor that has previously shown rapid and effective CSU disease control.
Novartis in chronic spontaneous urticaria (CSU)
Novartis is dedicated to reimagining the care of patients with diseases that can severely limit quality of life such as CSU, psoriasis, acne and atopic dermatitis.
Novartis is committed to developing medicines that will advance the treatment of CSU, so patients are able to live their lives without the distressing and unpredictable symptoms of this debilitating disease.
These include ligelizumab (QGE031) a high-affinity monoclonal anti-immunoglobulin E antibody and remibrutinib (LOU064), a highly selective, potent oral Bruton’s tyrosine kinase (BTK) inhibitor with a potential best-in-class profile for the treatment of autoimmune disorders.
Any new therapies will add to our portfolio of medicines that already includes Xolair® (omalizumab), our existing approved therapy for CSU.”
