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

EAST HANOVER, N.J., Feb. 24, 2013 /PRNewswire/ -- Late-breaking results from ASTERIA II, a Phase III placebo-controlled study, showed positive results in patients with moderate to severe chronic idiopathic urticaria (CIU), referred to as chronic spontaneous urticaria (CSU) outside the United States, who remained symptomatic despite treatment with approved antihistamine doses. The data were published today in the New England Journal of Medicine and will be presented tomorrow at the American Academy of Allergy, Asthma & Immunology (AAAAI) annual meeting in San Antonio, Texas. Omalizumab is not indicated for CIU.

The primary endpoint was measured using a 21-point scale known as a weekly Itch Severity Score (ISS). The study met its primary endpoint, showing that omalizumab given at doses of 150 mg and 300 mg every four weeks led to significant improvement from baseline at Week 12 in the mean weekly ISS from baseline (approximately 14 in all treatment groups) by 8.1 (p=0.001) and 9.8 (p<0.001), respectively, compared to a 5.1 improvement in patients on placebo. The omalizumab 75 mg dose group did not demonstrate statistical significance compared to placebo for the primary endpoint. All eight pre-specified secondary endpoints in the ASTERIA II trial were met for the 150 mg and 300 mg doses, 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.

CIU is a distressing skin condition characterized by red, swollen, itchy and sometimes painful hives on the skin, spontaneously presenting and reoccurring for more than six weeks. At any given time, the prevalence of CIU is 0.5% to 1% worldwide. While antihistamines are used first to treat CIU, more than 50% of patients are unable to achieve symptom relief with approved doses.

"These results indicate that omal
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SOURCE Novartis Pharmaceuticals Corporation
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