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Novartis Reports Omalizumab Significantly Improved Chronic Idiopathic Urticaria Symptoms in Patients Who Failed Standard Therapy
Date:2/24/2013

antihistamine. For the primary endpoint, the omalizumab 75 mg dose group did not demonstrate statistical significance compared to placebo. However, omalizumab 150 mg and 300 mg dose groups met the pre-specified primary endpoint and all eight pre-specified secondary endpoints in the ASTERIA II trial, except for the 150 mg dose that did not show a significant difference from placebo in the proportion of angioedema-free days from Week 4 to Week 12 of therapy. Patient response, as measured by the median time to Minimally Important Difference (MID) in itch severity score,  a secondary endpoint, occurred at Week 1 (300 mg dose) and Week 2 (150 mg dose), compared to Week 4 in the placebo group.

The incidence and severity of adverse events (AEs) was similar across treatment groups. The most frequently reported treatment-emergent adverse events in patients taking omalizumab (>10% in any omalizumab treatment arm) in the study (including treatment period and follow-up period) were nasopharyngitis (nasal and throat infection or common cold), idiopathic urticaria (hives and itching, trigger unknown) and headache.  Five (6.3%) patients experienced serious adverse events (SAEs) in the omalizumab 300 mg dose group, compared to two (2.5%) in the placebo group. In the 150 mg and 75 mg dose groups, one patient experienced SAEs in each group (1.1% and 1.3%, respectively). No deaths were reported during this study.

About Omalizumab
Omalizumab is not indicated for CIU.

Omalizumab is a biologic therapy unique in targeting immunoglobulin E (IgE). Research is ongoing to understand the mechanism of action of omalizumab in CIU and to investigate its potential impact on the drivers of CIU. Omalizumab is approved for the treatment of moderate to severe allergic asthma under the brand-name Xolair® in more than 90 countries, including the US since 2003 and the EU since 2005. In the US, Xolair is indicated for appropriate people who are
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SOURCE Novartis Pharmaceuticals Corporation
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