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Ligelizumab Receives FDA Breakthrough Therapy Designation

The FDA announced that ligelizumab has received the Breakthrough Therapy designation for the treatment of chronic spontaneous urticaria for patients who have had an inadequate response to H1-antihistamines.

FDA Breakthrough Therapy designations are granted to treatments that target a serious life-threatening disease and that demonstrate a potential substantial improvement over current therapies in at least one clinical primary endpoint.

Chronic urticaria can be frustrating and challenging for patients, often significantly affecting quality of life. It presents as itchy, painful wheals (also known as hives) or angioedema, but urticaria may also have both hives and swelling. To be considered chronic spontaneous urticaria, presentation should last at least 6 weeks and occur with no known cause, unlike inducible urticaria that can be caused by triggers such as exercise or cold.

“With so few treatment options available, patients are looking for more and better therapies to control their [chronic spontaneous urticaria],” said Angelika Jahreis MD, PhD, Novartis Global Head Development Unit Immunology, Hepatology & Dermatology, in the press release. “The FDA Breakthrough Therapy designation recognizes the need for a more effective treatment for this unpredictable, systemic and debilitating disease.”

Novartis ligelizumab (QGE031) receives FDA Breakthrough Therapy designation for patients with chronic spontaneous urticaria (CSU). Press release. Novartis; January 14, 2021. Accessed January 15, 2021.

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