FDA Expands Use of Asthma Drug Xolair to Treat Severe Food Allergies
(NEWSnet/AP) — Xolair, medication used to treat asthma, now may be used to reduce severe reaction in people who have a food allergy, U.S. Food and Drug Administration said.
Xolair, the brand name for the drug omalizumab, became the first medication approved to reduce allergic reaction caused by accidental exposure to food triggers.
Patients as young as age 1 with allergies may take the drug by injection every two to four weeks, depending on weight and their body’s response to allergens.
An estimated 17 million people in the U.S. have the type of food allergy that can cause rapid, serious symptoms, including severe, whole-body reactions that potentially are fatal.
People who use Xolair must continue to avoid the food that causes reaction, such as peanuts, cashews, hazelnuts, walnuts, milk products and eggs. The medication allows them to tolerate higher amounts of such food without causing a major reaction
FDA’s decision is based on a study led by Wood and funded by National Institutes of Health. It showed Xolair allowed about 68% of participants with peanut allergies to tolerate about 600 milligrams, or about 1/2 teaspoon, of peanut protein, compared with about 6% of those who received dummy injections.
Results were similar for other allergens, such as tree nuts, milk, egg and wheat, according to a study abstract. Full results are expected to be presented at a meeting and published in a peer-reviewed journal later in February.
Xolair is a monoclonal antibody, a type of treatment that works by blocking the body’s natural response to allergens. It was approved in 2003 and has been used to treat asthma, nasal polyps and chronic hives. It is produced by drugmakers Novartis and Roche and is distributed by a Roche subsidiary, Genentech.
The drug has been used “off-label” to treat food allergies, said Dr. Ruchi Gupta, director of Center for Food Allergy & Asthma Research at Northwestern University.
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