The drug, a prescription biologic medicine given as an injection under the skin, was approved as a treatment to cut the risk of allergic reactions that may occur among people age 1 and older with IgE-mediated food allergies, which are the most common type.
The drug is not intended to to be used as an emergency treatment of allergic reactions, and people taking the drug should continue to avoid foods they are allergic to, the FDA said.
“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,” Kelly Stone, MD, PhD, associate director of the division of pulmonology, allergy, and critical care in the FDA’s Center for Drug Evaluation and Research, said in a news release.
The approval marks the fourth FDA-approved indication for Xolair. It was first approved in 2003 to treat moderate to severe persistent allergic asthma in some patients. It’s made by Roche and Novartis.
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