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.
Novartis says it intends to move a drug for chronic spontaneous urticaria (CSU), a severe form of hives, into a phase III programme on the strength of a mid-stage study......