EC approves Xolair for children

The EC has approved Xolair (omalizumab) in patients aged six to eleven years, providing a new treatment approach to nearly 35,000 children in the EU with uncontrolled severe persistent allergic asthma.

Asthma is estimated to affect 10% of children in Europe. It is also the most common cause of school absenteeism, and often leads to the need for oral corticosteroid use in children. Despite conventional therapy, severe asthma remains uncontrolled in more than 50% of children with the condition.

“When a chronic and serious disease like asthma affects children, it can have life-changing and even life-threatening consequences,” said Joe Jimenez, CEO of the Novartis Pharmaceuticals Division. “This EC approval of Xolair offers young asthma patients new hope against this disease, in line with the Novartis commitment to develop innovative respiratory health solutions that meet patients’ and physicians’ needs.”

The EC approval was based in part on a study presented at the European Respiratory Society Annual Congress in 2008. The study showed that Xolair reduced asthma attacks by 34% after 24 weeks of treatment and provided an overall reduction of 50% at one year in patients aged six to eleven years.

In another study, Xolair, when used in children aged six to eleven, was shown to significantly reduce the need for oral corticosteroids. Children taking Xolair also missed 46% fewer school days.

By targeting an antibody involved in the underlying mechanism of allergic asthma, Xolair can prevent the onset of debilitating symptoms such as shortness of breath and wheezing in severely affected patients.

Xolair was approved as an add-on therapy in the EU in 2005 for patients aged twelve and older with severe persistent allergic asthma.