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Novartis' ligelizumab granted FDA Breakthrough Therapy Designation

Published on 14/01/21 at 11:26am

The FDA has granted Novartis’ ligelizumab Breakthrough Therapy Designation for the treatment of chronic spontaneous urticaria (CSU) in patients who have an inadequate response to H1-antihistamine treatment, the company announced today.

CSU is an unpredictable and severe disease of the skin, affecting between 0.5 and 1% of the global population at any time. It is characterised by the development of itchy, painful hives, swelling, or both, lasting for at least six weeks and occurring with no known cause. CSU can be challenging or frustrating for patients due to the severity and unpredictable nature, and most commonly persists for 1-5 years – but has been known to last longer.

According to FDA guidelines, treatments that receive Breakthrough Therapy Designation must target a serious or life-threatening disease and demonstrate a potential substantial improvement over existing therapies on one or more significant clinical endpoints.  

In a Phase IIb dose-finding trial, more patients experienced complete resolution of hives with ligelizumab compared with monoclonal antibody omalizumab. No safety concerns were found with Novartis’ drug compared with omalizumab or placebo in a Phase IIb dose-finding trial in CSU patients with inadequate control on antihistamines.

Ligelizumab compared with omalizumab is currently being investigated in ongoing Phase III clinical trial programmes including PEARL 1 and PEARL 2. The clinical trials have recruited more than 2,000 patients globally across 48 countries and results are expected in the second half of this year.

Dr Angelika Jahreis, of Novartis’ Global Head Development Unit for Immunology, Hepatology and Dermatology, 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 recognizes the need for a more effective treatment for this unpredictable, systemic and debilitating disease.”

Darcy Jimenez

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