Swiss drug major Novartis (NOVN: VX) has announced new analyses from pivotal Phase III registration studies showing Xolair (omalizumab) helps patients with chronic spontaneous urticaria (CSU) achieve significant improvements in quality of life measures.
CSU, which is known as chronic idiopathic urticaria (CIU) in the USA and Canada, is a severe skin condition with symptoms that include persistent itching, swelling and a rash that spontaneously appears on the skin and re-occurs for more than six weeks.
In pivotal Phase III studies (ASTERIA I, ASTERIA II and GLACIAL), Xolair was found to be highly effective in either reducing or eliminating CSU symptoms, in patients for whom previous therapies had failed. The studies evaluated the efficacy and safety of Xolair compared to placebo in nearly 1,000 CSU patients who remain symptomatic despite H1 antihistamines.
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