March 4, 2013

Novartis reported results from a phase III trial of omalizumab for the treatment of chronic idiopathic urticaria (CIU). This global, multi-center, randomized, double-blind, placebo-controlled study, ASTERIA II, enrolled 323 patients with moderate to severe CIU who remained symptomatic despite treatment with approved antihistamine doses. Subjects received omalizumab 75mg, 150mg or 300mg, or placebo, administered subcutaneously every four weeks, for a total of three doses within a 12-week treatment period, with a 16-week follow-up period. The study met its primary endpoint, showing that omalizumab given at doses of 150mg and 300mg 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 75mg 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 150mg and 300mg doses. Omalizumab was well tolerated. The more frequent adverse events were nasopharyngitis, idiopathic urticaria and headache. Novartis regulatory submissions are on track for 2013.

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