US FDA clears Xolair for chronic idiopathic urticaria

Swiss drug major Novartis (NOVN: VX) says the US Food and Drug Administration has approved Xolair (omalizumab) for the treatment of chronic idiopathic urticaria (CIU), an unpredictable and debilitating skin disease, also referred to as chronic hives.

In the USA, Xolair - which is being jointly developed and co-promoted in the USA by Novartis and Roche (ROG: SIX) subsidiary Genentech, is indicated for CIU in adults and adolescents (12 years of age and above) who remain symptomatic despite H1-antihistamine treatment. Until now, H1-antihistamines have been the only approved therapy for CIU. Xolair is already approved since 2003 in the USA as a treatment for allergic asthma.

"This approval from the FDA is great news for patients in the USA suffering from CIU, a skin disease known as CSU [chronic spontaneous urticaria] in other parts of the world," said David Epstein, division head of Novartis Pharmaceuticals, adding: "Up to 50% of patients do not respond to approved doses of H1-antihistamines, which up until now have been the only licensed treatment for CIU in the USA."