Omalizumab meets primary in Phase III for chronic idiopathic urticaria

Novartis AG (NYSE:NVS; SIX:NOVN) and the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) said subcutaneous omalizumab given every four weeks for 12 weeks as an add-on to antihistamine therapy met the primary endpoint in the Phase III ASTERIA II trial to treat chronic idiopathic urticaria (CIU). Specifically, 150 and 300 mg doses of omalizumab significantly reduced mean weekly Itch Severity Score from baseline to week 12 vs. placebo (p=0.001 and p<0.001, respectively). The 75 mg dose of omalizumab missed the endpoint (p=0.46). The double-blind, international trial enrolled 323 patients ages 12-75 with moderate to severe refractory CIU. Data were published in the New England Journal of Medicine and presented at the American Academy of Allergy, Asthma and Immunology meeting in San Antonio. ...