Novartis, Roche’s Xolair Help Blunt Severe Milk Allergies in Children

Novartis AG (NOVN) and Roche Holding AG (ROG)’s Xolair, a medication used to treat asthma attacks caused by allergens such as pollen and dust mites, helped children overcome milk allergies, a small study showed.

The research found that nine of 11 severely milk-intolerant children were able to consume 8 to 12 ounces of dairy each day after completing a desensitization regimen that included taking Xolair for 16 weeks. The study, the first to combine Xolair with food desensitization, was presented at the American Academy of Allergy, Asthma and Immunology meeting today in San Francisco.

About 3 million children in the U.S. have some form of food allergy, with milk the most common, ranging in severity from mild to life-threatening, according to the study. There is no cure for food allergies and no safe and effective treatments except to avoid the foods that cause reactions, the researchers said. The findings may help lead to a cure for severe food allergies, said study author Dale Umetsu.

“These findings give us hope that we can develop a treatment for patients with food allergies that is relatively safe and effective,” said Umetsu, a professor of pediatrics at Harvard Medical School and Children’s Hospital Boston, in a March 18 telephone interview. “What we hope to do and see is that this approach might work for other food allergies as well, not just milk allergy, but perhaps other allergies such as peanuts, tree nuts and those sorts of things.”

The children in the study had severe allergies, some of which were life threatening, Umetsu said.

No Approval for Under 12

Xolair was approved in the U.S. in 2003 to treat allergic asthma in adults and children aged 12 or older. Novartis and Roche’s Genentech unit, which helped support the study, failed to win U.S. clearance in 2009 for Xolair in children aged 6 to 11. Novartis and Roche are based in Basel, Switzerland.

Christopher Vancheri, a spokesman for Roche’s Genentech unit, said in a March 18 e-mail that the companies aren’t currently conducting studies in children with milk allergies. He said it’s premature to speculate whether they will pursue such tests, or seek U.S. Food and Drug Administration approval for Xolair’s use against milk allergies if larger studies show positive results.

Xolair works in the body by attaching itself to immunoglobulin E, an antibody responsible for allergic reactions. The drug, the only one of its kind on the market, brings the molecule out of circulation or pulls it from cells to reduce allergic reactions.

Study Results

In the study, researchers from Children’s Hospital Boston and Stanford University Medical Center in Palo Alto, California, gave 11 children ages 7 to 17 injections of Xolair for nine weeks. The kids were then given small amounts of milk while continuing seven more weeks of injections to help block their allergic reactions. Xolair was then stopped and the patients continued to receive about 2 ounces of milk daily for another 8 weeks.

The children were tested by a nutritionist to see if they were able to consume foods with milk powder added without side effects. Nine of 11 did, the researchers said. The next day, the nine children began to have 8 ounces to 12 ounces of dairy a day to maintain their tolerance.

Building tolerance to milk in people with severe allergies by having them digest small and incrementally larger doses at a time could take months to years, Umetsu said. Most times they will have side effects including hives, diarrhea, vomiting and asthma, and some will drop out of the study because of the reactions, he said. Xolair accomplished tolerance building in 24 weeks, the study found.

Further Study Needed

Larger studies are needed to confirm these findings and to determine who will benefit most from the treatment before doctors can start using Xolair in kids with food allergies, said lead study author Kari Nadeau in a March 18 telephone interview.

“We are trying to make sure that everyone with food allergies has different options available to them either with or without Xolair,” said Nadeau, an assistant professor in the division of Immunology and Allergy at Stanford. “To be able to cure food allergy is fantastic. My hope is this will allow more options for curing food allergies.”

Umetsu, Nadeau and Lynda Schneider, also from Children’s Hospital Boston, said they are planning a similar study in children with peanut allergies.

More than 12 million Americans, or 1 in 25, have food allergies, according to the Food Allergy & Anaphylaxis Network, which provides information about food allergies. Food allergies occur most often in young children. About 1 in 17 kids under the age of 3 have a food allergy, according to the network’s Web site.

The most common culprits are milk, eggs, peanuts, tree nuts including walnuts, almonds and pecans, wheat, soy, fish and shellfish.

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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