Novartis Childhood Asthma Drug Xolair Approved in EU

23 August 2009 (Last Updated August 23rd, 2009 18:30)

The European Commission (EC) has granted approval to Novartis' Xolair, an add-on therapy for severe persistent allergic asthma in children. Xolair has so far only been approved for use in patients aged 12 years and older as the only approved therapy in the EU that blocks the action of i

The European Commission (EC) has granted approval to Novartis' Xolair, an add-on therapy for severe persistent allergic asthma in children.

Xolair has so far only been approved for use in patients aged 12 years and older as the only approved therapy in the EU that blocks the action of immunoglobulin E (IgE), an antibody involved in the underlying mechanism of allergic asthma.

Novartis Pharmaceuticals Division's CEO Joe Jimenez said that asthma can have life-changing and even life-threatening consequences for children.

"This approval offers young asthma patients new hope against this disease," Jimenez said.

EC approval was based on studies presented at the European Respiratory Society Annual Congress in 2008 that showed 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 11 years.

Asthma is a chronic lung disease that causes recurrent attacks of breathlessness and is estimated to affect 10% of children in Europe. Asthma is also the most common cause of school absenteeism.