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FDA approves Genetech’s Xolair injection for severe food allergies


HQ Team

February 19, 2024: The Food and Drug Administration (FDA) has approved Genetech’s Xolair (omalizumab) injection for severe food allergies in certain adults and children 1 year or older, including reducing the risk of anaphylaxis.

Patients who take Xolair must continue to avoid foods they are allergic to. It is not approved for immediate emergency treatment of allergic reactions. 

It is recommended to be taken repeatedly every few weeks to help reduce the risk of reactions over time.”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,” said Kelly Stone with the FDA’s Center for Drug Evaluation and Research.

“Xolair offers patients and families an important new treatment option that can help redefine the way food allergies are managed and reduce the often-serious allergic reactions that can result from exposure to food allergens,” said Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of Global Product Development. “Today’s approval builds on 20 years of patient experience and an established efficacy and safety profile since Xolair was first approved in allergic asthma. We look forward to bringing this treatment to the food allergy community who have long awaited an advancement.”

Xolair has already been approved by the FDA to treat some cases of persistent asthma triggered by allergies, chronic hives, and chronic inflammatory sinus disease with nasal polyps


The FDA approval is based on the Phase III OUtMATCH study, which evaluated Xolair in patients aged 1 to 55 years allergic to peanuts and at least two other food allergens, including milk, egg, wheat, cashew, hazelnut and walnut. The OUtMATCH study is sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID). The trial included 168 patients who were allergic to peanuts and at least two other foods. They were administered with Xolair for  68% for 4 to 5 months and after this period, 68% percent were able to consume about 2.5 peanuts without symptoms like body hives or vomiting, according to the FDA.

The cost of the medication ranges from $2,900 a month for children and $5,000 a month for adults.

Some of the most common side effects include fever and a reaction to the injection site. The drug also warns that the medication itself can trigger anaphylaxis. Genentech advises that a health care provider monitors a person who is starting to use Xolair.

About 3.4 million children and 13.6 million adults in the U.S. have been diagnosed with IgE-mediated food allergies (Immunoglobulin E (IgE)-mediated food allergies are the most common type and are typically characterized by the rapid onset of symptoms following exposure to certain food allergens), according to the Centers for Disease Control and Prevention. Food allergy prevalence has been on the rise for the past 20 years. There are 160 different foods that cause IgE-mediated food allergy.

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