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EC Approves Novartis’ Xolair

To treat children aged 6 to 11 years suffering from severe persistent allergic asthma

Novartis has reported that the European Commission (EC) has approved Xolair (omalizumab) as add-on therapy for severe persistent allergic asthma in children aged 6 to 11 years.

Reportedly, the EC’s approval was based, in part, on a study presented at the European Respiratory Society Annual Congress in 2008. It showed that Xolair reduced asthma attacks by 34% after 24 weeks of treatment and has provided an overall reduction of 50% at one year in patients aged 6 to 11 years.

The company said that Xolair also showed an overall safety and tolerability profile, consistent with that observed in the adult and adolescent population.

Joe Jimenez, CEO of Novartis’ Pharmaceuticals Division, said: When a chronic and serious disease like asthma affects children, it can have life-changing and even life-threatening consequences. 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.