FDA approves food allergy drug to lessen severity of reactions to peanuts, dairy and more
FILE - Testing for certain food allergies on a boys skin. (Photo By BSIP/Universal Images Group via Getty Images)
WASHINGTON - A new food allergy drug has been approved by the U.S. Food and Drug Administration, potentially lessening the severity of reactions to foods like peanuts, milk, eggs, wheat, and cashews.
The injectable Xolair (omalizumab) is the first medication approved by the FDA to reduce allergic reactions after accidental exposure, according to an agency announcement on Feb. 16.
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It was approved for "immunoglobulin E-mediated food allergy in certain adults and children 1 year or older," the FDA said.
Dr. Robert A. Wood, a principal investigator of the multicenter study that led to the FDA approval, called the drug potentially "life-changing for people with food allergies."
"Treatment options, aside from strict avoidance, have been very limited for the millions of Americans with severe food allergies," Wood, director of the Division of Pediatric Allergy, Immunology and Rheumatology at Johns Hopkins University School of Medicine in Baltimore, Maryland, told FOX News Digital.
"The lives of these patients and their families are often consumed by fear of accidental exposure to food allergens — and even with strict avoidance, accidental exposures are common."
"The approval of Xolair for the treatment of food allergy will be very meaningful, and potentially even life-changing, for people with food allergies," Wood added.
The FDA noted that individuals should still avoid foods they're allergic to even if they take Xolair. It is also not approved for the immediate emergency treatment of allergic reactions, such as anaphylaxis.
"This newly approved use for Xolair will provide a treatment option to reduce the risk of harmful allergic reactions among certain patients with IgE-mediated food allergies," Kelly Stone, M.D., PhD, associate director of the Division of Pulmonology, Allergy and Critical Care in the FDA’s Center for Drug Evaluation and Research, said in an FDA news release.
"While it will not eliminate food allergies or allow patients to consume food allergens freely, its repeated use will help reduce the health impact if accidental exposure occurs."
Xolair’s safety and efficacy in reducing food allergy reactions was analyzed in a multi-center, double-blind, placebo-controlled study of 168 children and adult patients – at least 1 year of age or older, the FDA said.
The participants were allergic to peanuts and at least two other foods, including milk, egg, wheat, cashew, hazelnut or walnut, the agency said.
Xolair (omalizumab) serves as risk reducer, and not cure
Nearly 6% of U.S. adults and children suffer from food allergies, according to the U.S. Centers for Disease Control and Prevention — and more than 40% of children with food allergies in the U.S. have been treated in the emergency department.
There is currently no cure for food allergies, and the CDC recommends strict avoidance of any foods that cause them.
Milk, eggs, fish, crustacean shellfish, wheat, soy, peanuts, and tree nuts account for the most serious allergic reactions in the U.S., according to the agency.
Meanwhile, sesame was officially added last year to the FDA's list of major food allergens.
IgE-mediated food allergies — the most severe — occur when the body’s immune system mistakenly perceives a food particle as a harmful invader.
A type of antibody called immunoglobulin E (IgE) contributes to the immune response, which can include stomach issues, itching, hives or anaphylaxis, according to several health experts.
Xolair can help lessen this immune response by targeting certain receptors in the body.
"It is an injection that works on blocking IgE, reducing the risk of an allergic reaction, but needs to be taken regularly to work," Dr. Fred Davis, associate chair of emergency medicine at Northwell Health in New Hyde Park, New York, told FOX News Digital.
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This story was reported from Cincinnati. FOX News contributed.