March 16, 2011 -- The asthma drug Xolair (omalizumab) improves asthma control, nearly eliminates seasonal flare-ups, and allows reductions in the doses of other asthma control medications in children as young as 6, according to a new study.
Xolair is approved by the FDA for use only in people 12 and older who have moderate to severe allergic asthma. In the clinical trial, Xolair was tested in children and young adults aged 6 to 20 and compared to placebo.
“We reduced symptom days by about 25%,” says researcher William W. Busse, MD, professor of medicine at the University of Wisconsin School of Medicine and Public Health, Madison. "And we reduced exacerbation rates [the number of attacks] by about 30%.''
As good as he says those results are, Busse says, ''that wasn't the important part." His team found that the spike in asthma attacks typically seen in the fall and linked with colds and other airway infections was virtually eliminated in the children taking Xolair. "It indicates in these kids that allergy seems to play an important role in their asthma," he tells WebMD.
Another expert who reviewed the study, however, is not convinced that the drug merits more widespread use. Zab Mosenifar, MD, a pulmonologist who is executive vice chair of the department of medicine and a professor of medicine at Cedars-Sinai Medical Center in Los Angeles, balks at the cost, among other factors.
According to the manufacturer, Genentech, the typical cost for the injected drug is $1,700 a month.
"Industry has been looking for a means of expanding the use of this agent," says Mosenifar, noting that its use is not widespread in patients 12 and older, by his observations.
Xolair is a biologic drug that works by blocking antibodies called IgE, which in excess can trigger symptoms of allergic asthma, including shortness of breath, coughing, and wheezing.
Four years after its approval in 2003, the FDA required Genentech Inc. (which now markets the drug together with Novartis) to add to the label a boxed warning -- commonly called a ''black box" warning -- to caution users that the drug may cause anaphylaxis. That’s a serious condition in which a person has trouble breathing, the chest becomes tight, and the throat and mouth swell.
In clinical trials, about one in 1,000 people reported anaphylaxis. Malignances have been another issue. In clinical trials, 0.5% of people on the drug reported cancers of the skin, breast, and other sites, compared to 0.2% of people on placebo.
In 2009, the FDA began to evaluate findings from an ongoing study of Xolair that suggests a link with heart disease and cerebrovascular problems, although it has not yet suggested any changes based on the interim findings.