Novartis receives EU approval for asthma drug Xolair for 6 to 11 year-olds

Swiss drugmaker Novartis" asthma drug Xolair (omalizumab) has been approved by the European Commission as add-on therapy for children aged 6 to 11 years suffering from severe persistent allergic asthma. In 2005 Xolair was approved for use in patients aged 12 years and older.

Asthma is estimated to affect 10% of children in Europe. Novartis says 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 this condition.

"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," said Joe Jimenez, chief executive of the Novartis pharmaceuticals division.

EC approval was based in part on a landmark study, presented at the European Respiratory Society Annual Congress in 2008, showing 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 6 to 11 years.

Novartis said that approved as add-on therapy, Xolair offers a new treatment approach to nearly 35,000 children in the EU with uncontrolled severe persistent allergic asthma.

The drug is currently approved in 63 countries and has been used to treat more than 62,000 patients

Xolair, a humanised monoclonal antibody, blocks the action of immunoglobulin E (IgE), an antibody involved in the underlying mechanism of allergic asthma. By targeting IgE, Xolair can prevent the onset of debilitating symptoms, such as shortness of breath and wheezing, in severely affected patients.