A new clinical study shows that Xolair (omalizumab), an innovative treatment for allergic asthma in adolescents and adults, significantly reduced asthma attacks in children aged six to 11 years with uncontrolled moderate-to-severe persistent allergic asthma.
Swiss drug major Novartis manufactured Xolair and in the US, it is co-promoted by Novartis Pharmaceuticals Corporation and Genentech. The study shows, Xolair is a unique treatment which blocks the action of IgE. By targeting the underlying mechanism of the disease, Xolair can prevent the onset of debilitating symptoms, such as wheezing and shortness of breath, in severely affected patients.
Results of a phase III study in children were presented at the annual meeting of the European Respiratory Society (ERS) in Berlin.
The study showed that after 24 weeks, children treated with Xolair suffered 31 percent fewer clinically significant exacerbations than those receiving placebo or dummy drug. The study therefore met its primary endpoint. Over the entire one-year study, children treated with Xolair suffered 54.2 percent fewer exacerbations than those on placebo. Xolair was generally safe and well-tolerated in the clinical trial with no differences in adverse events compared with placebo.
"These data represent an important new approach to treating allergic asthma in children who remain uncontrolled despite their treatment," said Prof Bobby Lanier of the University of North Texas Health Science Center, US. "These children are particularly vulnerable and their lives can be severely affected or even cut short by this disease."
Xolair is approved for adults and adolescents (aged 12 years or above) with moderate to severe persistent asthma in the US, and with severe allergic asthma in the EU.
"Xolair continues to improve the lives of asthma patients across the world, and Novartis is excited about the future opportunity to extend the use of this breakthrough treatment to help younger patients and their families," said Dr Trevor Mundel, Head of Global Development Functions at Novartis Pharma.
Asthma causes children to lose many school days and may limit their academic achievements and harm social relationships. Despite treatment, nearly 497,000 children were hospitalized for asthma in the US alone in 2004.