Novartis' Xolair shows results in children

Swiss drug major Novartis presented data from a Phase III trial confirming its Xolair (omalizumab) treatment for allergic asthma in adolescents and adults significantly reduced exacerbations in children aged six to ll years with uncontrolled moderate-to-severe persistent allergic asthma at the European Respiratory Society conference in Berlin, Germany.

The double-blind, placebo-controlled study showed that, after 24 weeks, children treated with Xolair suffered 31% fewer significant exacerbations than those receiving placebo (p=0.007). The study therefore met its primary endpoint. Over the entire one-year trial, children treated with the Novartis drug suffered 43% fewer exacerbations than those in the control group (p<0.001). The firm says Xolair was generally safe and well-tolerated with no differences in adverse events compared with placebo. Worldwide submissions for the drug in pediatric indications are forthcoming.