FDA files Genentech's supplemental biologics license application of Xolair (omalizumab) for chronic idiopathic urticaria (CIU)

CIU is a skin condition characterized by red, swollen, itchy hives on the skin. Currently, H1-antihistamines are the only approved therapy for patients suffering from CIU, also known as chronic spontaneous urticaria (CSU). FDA decision on sBLA expected during second quarter of 2014. Roche 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), a form of chronic hives 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.
Source: Roche Investor Update - Category: Pharmaceuticals Source Type: news