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Novartis receives approval in EU for Xolair

Novartis announced today that the European Commission (EC) has approved Xolair (omalizumab) as add-on therapy for severe persistent allergic asthma in children age 6 to 11 years. Xolair is the only approved therapy that targets an underlying mechanism of asthma and is already approved for use in patients aged 12 years and older. 

Asthma is a chronic lung disease, characterised by recurrent attacks of breathlessness, that is estimated to affect 10 percent 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 percent of children with this 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.”

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 percent after 24 weeks of treatment and provided an overall reduction of 50 percent at one year in patients age 6 to 11 years. Xolair also demonstrated a good overall safety and tolerability profile, consistent with that observed in the adult and adolescent population.

In another study, Xolair, when used in children age 6 to 11, was shown to significantly reduce the need for oral corticosteroids. Children taking Xolair also missed 46 percent fewer school days.

Xolair, a humanized monoclonal antibody, is a unique treatment which 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. Xolair was approved as add-on therapy in the EU in 2005 for patients 12 years and older with severe persistent allergic asthma. Xolair is currently approved in 63 countries and has been used to treat more than 62,000 patients.