This morning, Novartis (NVS) announced that it has received approval from the European Commission (EC) for the use of Xolair (omalizumab) as an add-on therapy for severe persistent allergic asthma in children in the age group of 6 to 11 years.
The approval is positive news for the company and should expand the patient base for the drug. Asthma is a chronic lung disease which is estimated to affect about 10% of children in Europe. It is also the most common cause of school absenteeism and children often use oral corticosteroids to deal with the disease. However, despite conventional therapy, severe asthma remains uncontrolled in more than 50% of children with this condition.
Xolair is a humanized monoclonal antibody aimed at treating the underlying mechanism of allergic asthma. The product works by blocking the action of immunoglobulin E (IgE). This helps in preventing the onset of debilitating symptoms, such as shortness of breath and wheezing, in severely affected patients.
Xolair’s approval for the 6-11 age group was based partly on data from a landmark study which showed that the product reduced asthma attacks by 34% after 24 weeks of treatment. Treatment with Xolair also led to a 50% reduction in asthma attacks at one year in patients age 6 to 11 years.
The product’s overall safety and tolerability profile was consistent with that observed in the adult and adolescent population. These results were presented at the European Respiratory Society Annual Congress in 2008.
Another study showed that Xolair, when used in children age 6 to 11, significantly reduced the need for oral corticosteroids. The rate of absenteeism was also found to be lower in children taking Xolair. Xolair is already approved for use in patients aged 12 years and older with severe persistent allergic asthma.
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