A new analysis of results from seven clinical studies published recently shows that Xolair (omalizumab) - a first-in-class therapy that targets a root cause of allergic disease - significantly reduced the number of asthma exacerbations (attacks) and almost halved the rate of emergency visits. The studies involved more than 4,300 patients with severe persistent asthma, who were inadequately controlled despite receiving the therapy specified in current guidelines.
Results from all seven studies are included in the application submitted to the Committee for Medicinal Products for Human Use (CHMP), which is currently evaluating whether Xolair should be approved for use in EU countries, a release from Novartis said.
Xolair is a monoclonal antibody that is given by subcutaneous injection every two or four weeks, and targets IgE (immunoglobulin E) which triggers the cascade of inflammatory symptoms in patients affected by diseases such as allergic asthma. Its efficacy is demonstrated by the review published in Allergy, in which data from seven studies were pooled to determine the effect of Xolair on asthma exacerbations in patients with severe persistent asthma. Xolair was added to current asthma therapy and compared either with placebo (in five double-blind studies), or with current asthma therapy alone (in two open-label studies), release from Novartis said.
Xolair was also shown to reduce the need for inhaled corticosteroids, to improve asthma symptoms and lung function, and to improve asthma-related quality of life. The authors of the report, led by the editor of Allergy, Prof Jean Bousquet of Hôpital Arnaud de Villeneuve, Montpellier, France, stated: "The decreases in the rates of asthma exacerbations and those requiring emergency care, are highly relevant to the management of patients with severe asthma."
A total of 15 million people worldwide are estimated to suffer from severe persistent asthma and are therefore at high risk of experiencing severe and potentially fatal attacks. One in every 250 deaths throughout the world is thought to be due to asthma-related causes, and the total costs associated with asthma are greater than those for tuberculosis and HIV/AIDS combined.
Importantly, the data show that response to Xolair was even more pronounced in individuals known to be at greatest risk of asthma-related death. A sub-analysis of three placebo controlled studies8 showed that Xolair reduced the rate of asthma exacerbations by 55% vs. placebo (p < 0.0004) in 254 patients who were defined as high-risk on the basis of an overnight hospitalisation, intensive care unit stay or emergency room visit in the past year, or any prior intubation, release added.
It has been developed under an agreement between Novartis Pharma AG, Genentech, Inc., and Tanox, Inc. Health authorities in the EU are expected to announce their decision on Xolair approval later this year.
The summary of data appears in Allergy, the peer-reviewed journal of the European Academy of Allergology and Clinical Immunology (EAACI).