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

izumab could potentially be an important addition in the treatment of chronic idiopathic urticaria, a disease that can have a significant impact on patients and can be challenging to manage," said Tim Wright , Global Head of Development, Novartis Pharmaceuticals. "We are committed to helping patients with this disease and look forward to receiving further results from ongoing longer-term clinical trials."

ASTERIA II is the first Phase III data to be presented from a clinical trial program in CIU, which also includes two additional studies investigating the efficacy and safety profile of omalizumab over 24 weeks treatment duration. Novartis regulatory submissions are on track for 2013.

"These results are encouraging news for appropriate patients whose CIU is unresponsive to antihistamines," said study co-lead investigator, Thomas Casale , MD, Chief of Allergy & Immunology at Creighton University Medical Center and Professor of Medicine and Medical Microbiology at Creighton University, Omaha, NE. "New and effective therapeutic strategies for CIU are necessary as treatment options are limited for these patients."

Study Details
ASTERIA II was a global, multi-center, randomized, double-blind study that evaluated the efficacy and safety profile of omalizumab compared to placebo and involved 323 patients aged between 12 and 75 with a diagnosis of moderate to severe CIU for at least six months. Patients were required to have the presence of itch and hives for at least eight consecutive weeks at any time prior to enrollment despite use of approved doses of H1 antihistamine treatment. Patients were randomized to omalizumab 75 mg, 150 mg or 300 mg or placebo, given subcutaneously every four weeks, for a total of three doses within a 12-week treatment period, with a 16-week follow-up period. Patients continued to receive stable doses of their pre-randomization H1
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SOURCE Novartis Pharmaceuticals Corporation
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