Xolair (omalizumab), Novartis’ biologic treatment for allergic asthma, significantly reduced the number of asthma attacks and almost halved the rate of emergency visits, according to a new analysis of the results of seven clinical trials published in the journal, Allergy.
The studies, which involved more than 4,300 patients with severe persistent asthma, who were inadequately controlled despite receiving the therapy specified in current guidelines, are included in the drug’s marketing application that is currently being reviewed by the European regulators [[02/07/04a]]. The review shows that Xolair reduced the rate of asthma exacerbations by 38% versus placebo. Overall, the total number of emergency visits was reduced by 47% in Xolair-treated patients, including reductions of 61% in emergency room visits and 52% in hospital admissions. The drug 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. 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 studies showed that Xolair reduced the rate of asthma attacks by 55% compared to placebo in 254 patients who were defined as high-risk.
Xolair won US approval back in June 2003 [[23/06/03b]], after having originally been knocked back by the agency in 2001, which requested additional preclinical and clinical data analyses, in addition to pharmacokinetic information [[11/07/01a]]. Health authorities in the EU are expected to announce their decision on Xolair approval later this year.
A total of 15 million people worldwide are estimated to suffer from severe persistent asthma and are 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 number of asthma cases is predicted to rise by another 100 million by 2025.