People with food allergies may now be able to prevent severe reactions with the use of the asthma medicine Xolair.
The U.S. Food and Drug Administration announced on Friday that people with food allergies may now use an asthma drug to help prevent severe reactions. Omalizumab, sold under the trade name Xolair, was the first treatment to be approved specifically to lessen allergic reactions brought on by unintentional contact with food allergens. Depending on their weight and body’s reaction to allergens, patients with allergies as young as one year old can have an injection of the medication every two to four weeks. Food allergies of the kind that can result in immediate, severe symptoms, including possibly fatal whole-body reactions, are thought to affect 17 million people in the United States.
People who use Xolair must continue to avoid foods that cause reactions, such as peanuts, cashews, hazelnuts, walnuts, milk products and eggs. The medication allows them to tolerate higher amounts of such foods without causing major reactions. Many people with allergies—and their families—live with constant anxiety about exposure to allergens and often avoid dining out and other social situations.
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Expanding The Use Of Xolair
“Having this protection is going to be life-changing,” stated Dr. Robert Wood, who oversees the Johns Hopkins Children’s Center’s pediatric allergy division. The National Institutes of Health-funded study headed by Wood served as the foundation for the FDA’s ruling. It revealed that, in comparison to around 6% of individuals who received fake injections, roughly 68% of participants with peanut allergies were able to take roughly 600 milligrams, or roughly 1/2 teaspoon, of peanut protein while using Xolair.
The results were similar for other allergens such as tree nuts, milk, egg and wheat, a study abstract reported. The full results are expected to be presented at a meeting and published in a peer-reviewed journal later this month. Wood estimated that 25% to 50% of people with food allergies, particularly children and young adults, would elect to use Xolair. The drug has been used “off-label” to treat food allergies, said Dr. Ruchi Gupta, director of the Center for Food Allergy & Asthma Research at Northwestern University. She welcomed full approval of the product.
Xolair is a monoclonal antibody, a type of treatment that works by blocking the body’s natural response to allergens. It was first 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 most common side effects of Xolair are injection site reactions and fever, but the FDA noted that the drug has also been associated with joint pain, rash, parasitic infections, malignancies and abnormal laboratory tests. Xolair comes with a warning saying the treatment itself can cause anaphylaxis and must be started in a health care setting equipped to manage the reaction.
The medication is not approved for emergency treatment of allergic reactions. The list price for Xolair ranges from about $2,900 a month for children to $5,000 a month for adults, according to Genentech. Most insured patients typically pay less out of pocket, the company said.
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