FDA Files sBLA for Xolair in Patients with Chronic Idiopathic Urticaria

The FDA accepted and filed Genentech'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. The filing was primarily based on two Phase III studies (ASTERIA I and ASTERIA II) evaluating a total of 642 patients with moderate-to-severe CIU who remained symptomatic despite treatment with H1-antihistamine therapy at approved doses. A third study (GLACIAL) evaluate the safety profile of Xolair as an add-on therapy in CIU patients who remained symptomatic despite other treatments with antihistamines. XOLAIR® (omalizumab) is currently indicated for patients 12 years of age and older with moderate to severe persistent allergic asthma caused by year-round allergens in the air. It was jointly developed by Genentech and Novartis Pharma AG and is co-marketed in the US with Novartis Pharmaceuticals Corporation. The FDA action date is second quarter of 2014.