Genentech, a member of the Roche Group RHHBY,
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
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