FDA Accepts Genentech's SBLA forXolair for Chronic Idiopathic Urticaria

Genentech, a member of the Roche Group

, today announced that the U.S. Food and Drug Administration (FDA) has accepted and filed the company's supplemental Biologics License Application (sBLA) for subcutaneous use of Xolair® (omalizumab) in people with Chronic Idiopathic Urticaria (CIU) who remained symptomatic despite treatment with H1-antihistamine therapy at approved doses. Xolair is jointly developed by Genentech and Novartis Pharma AG and is co-marketed in the United States with Novartis Pharmaceuticals Corporation. The FDA action date is second quarter of 2014. CIU, also known as chronic spontaneous urticaria (CSU), is a skin condition characterized by red, swollen, itchy hives.1,3 It is