Novartis, Roche’s Xolair Blunts Asthma Attacks in Children in U.S. Cities
By Nicole Ostrow - Mar 16, 2011 2:00 PM PT
Xolair, sold by Novartis AG (NOVN) and Roche Holding AG (ROG), improved treatment of asthma for inner-city children and young adults, according to a U.S.-funded study.
Those given an injection of Xolair had fewer days with symptoms, such as wheezing and shortness of breath, and fewer asthma attacks compared with those on a placebo, researchers said today in the New England Journal of Medicine. The patients who responded best were those most allergic to cockroaches.
About 7.1 million U.S. children under the age of 18 have asthma, according to the American Lung Association, based in Washington. Reducing children’s allergic reactions can help them have fewer asthma attacks, said William Busse, the study’s lead author, in a telephone interview yesterday.
“The take-home message for physicians and parents is to realize that allergies play an important role in making children more susceptible to viral respiratory infection-provoked asthma attacks, especially those that occur on a seasonal basis,” said Busse, a professor of medicine at the University of Wisconsin School of Medicine and Public Health, in Madison.
Asthma attacks are more likely in spring and autumn, the seasons when more allergens are in the air and respiratory viruses rise, according to the U.S. National Institutes of Health, based in Bethesda, Maryland. The agency backed the study.
Xolair works in the body by attaching itself to immunoglobulin E, an antibody responsible for allergic reactions, Busse said. The drug brings the molecule out of circulation or pulls it from cells to reduce allergic reactions, he said. Xolair is the only drug in its class, he said.
Age Limit
The medicine costs about $1,000 a month and is usually covered by insurance, Busse said. Novartis’s 2010 sales of Xolair were $369 million, while Genentech’s revenue from the product totaled $616 million, according to data in the companies’ annual reports.
Xolair was approved in the U.S. in 2003 for use in adults and children aged 12 or older. Novartis, which also helped support today’s study, and Roche’s Genentech unit failed to win U.S. clearance in 2009 for Xolair in children aged 6 to 11.
Christopher Vancheri, a Genentech spokesman, said yesterday that the companies have no plans to seek U.S. approval again for children under 12. Both Novartis and Roche are based in Basel, Switzerland.
“Allergic asthma is a growing problem among inner-city children,” Vancheri said in an e-mail. The study provides “new information that continues to help further the understanding of the mechanism of asthma in this population.”
National Network
The study covered 419 patients aged 6 to 20 who had moderate to severe allergic asthma for more than a year. The children came from Boston, Chicago, Cleveland, Dallas, Denver, New York, Washington and Tucson, Arizona. The patients were recruited by clinics in the Inner City Asthma Consortium, a nationwide network supported by the NIH.
The researchers sought to determine if adding Xolair, or omalizumab, to standard therapy reduced the number of days of asthma-related symptoms and the severity of attacks. U.S. guidelines call for patients to use inhaled corticosteroids, visit doctors and limit exposure to allergens.
The participants in the 60-week trial were split into two groups. One received Xolair and followed the guidelines for asthma therapy. The other group received a placebo and followed guidelines.
Hospital Visits
The patients taking Xolair had a 75 percent reduction in hospitalizations, according to the report. Xolair reduced the number of days with asthma symptoms to 1.48 in two weeks compared with 1.96 for those given a placebo, while lowering the proportion of people who had serious attacks to 30 percent from 49 percent, the study found. Xolair also almost eliminated seasonal rises in the episodes.
“No differences of concern regarding safety were noted between the two groups,” the researchers wrote. Severe allergic reactions called anaphylactic events were reported in seven patients, including just one on Xolair. Such reactions can lead to death, according to safety information on Xolair.com, a website maintained by Genentech and Novartis.
Busse said it was too soon to recommend that doctors give Xolair to kids under 12 for asthma and that longer-term research is needed. The Inner City Asthma Consortium is planning to study whether giving children Xolair for a short period before going back to school can reduce asthma attacks, he said.
“We continue searching for therapeutic strategies to reduce the enormous burden of asthma,” said Daniel Rotrosen, director of the National Institute of Allergy and Infectious Diseases’s Division of Allergy, Immunology and Transplantation program, which oversees the asthma network, in a statement.
To contact the reporter on this story: Nicole Ostrow in New York at nostrow1@bloomberg.net.
To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net
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