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US breakthrough designation for ligelizumab in chronic spontaneous urticaria
15th January 2021
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.
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