The US Food and Drug Administration (FDA) has granted Novartis’ ligelizumab a breakthrough therapy designation for the treatment of patients with chronic spontaneous urticaria (CSU) who have an inadequate response to H1-antihistamine treatment.

Ligelizumab – also known as QGE031 – is a monoclonal anti-immunoglobulin E (IgE) antibody that is though to work by blocking the IgE/FcεRI pathway which is lays a key role in the inflammatory process in CSU.

CSU, which affects 0.5-1% of the global population, is characterised by the development of hive, swelling (angiodema), or both – lasting for at least six weeks and occurring with no known cause.

In a Phase IIb trial, more patients experienced complete resolution of hives with ligelizumab compared to Novartis’ older drug Xolair (omalizumab).

Novartis is currently investigating ligelizumab, compared with Xolair, in ongoing Phase III clinical trial programmes, which have recruited over 2,000 patients globally across 48 countries – results are expected in the second half of 2021.

“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,” said Angelika Jahreis, global head development unit Immunology, Hepatology & Dermatology, Novartis.

“The FDA breakthrough therapy designation recognises the need for a more effective treatment for this unpredictable, systemic and debilitating disease,” she added.