Results indicate that patients with inadequately controlled severe persistent asthma, who are at high risk of life-threatening attacks, substantially benefit from treatment with omalizumab, marketed as Xolair. These patients not only experience fewer serious asthma attacks but receive a significantly improved asthma-related quality of life.
A total of 419 patients, aged 12-75, were recruited for the multicenter study. All participants had reduced lung function and a recent history of clinically significant exacerbations, despite receiving prior treatments. Aside from the therapeutic benefits, the drug had few side affects and was shown to be well-tolerated in both adults and children.
Xolair is a first-in-class therapy that is given by injection every two or four weeks. It works by blocking the action of IgE, the antibody responsible for triggering the cascade of allergic symptoms in patients with diseases such as allergic asthma.
Novartis believes the treatment offers a novel therapeutic approach to the control of asthma symptoms such as wheezing and shortness of breath, even in the most difficult-to-treat patients whose condition remains poorly-controlled despite receiving the best available therapy.
Xolair was launched in the US in July 2003, and is also approved in Australia, Brazil, Canada, Dominican Republic, Guatemala, Israel, New Zealand and Venezuela. It has been developed under an agreement between Novartis, Genentech, and Tanox. The European Medicines Agency (EMEA) is due to announce its decision on Xolair approval later this year.