FDA approves Xolair for Immunoglobulin E-mediated food allergies
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Key takeaways:
- 68% of patients given Xolair tolerated 600 mg of peanut protein after 16 to 20 weeks of treatment.
- Further results will be revealed at the American Academy of Allergy, Asthma & Immunology annual meeting.
The FDA has approved Xolair for the reduction of allergic reactions, including anaphylaxis, that may occur with exposure to one or more foods in children and adults with Immunoglobulin E-mediated food allergy.
According to a release from Roche, approval was based on positive data from the phase 3 OUtMATCH study, conducted at 10 sites across the United States, which evaluated Xolair (omalizumab) in participants aged 1 to 55 years with an allergy to peanuts and at least two other products, including milk, egg, wheat, cashew, hazelnut and walnut.
According to data cited in the release, 68% of participants in the study who were treated with Xolair for 16 to 20 weeks tolerated at least 600 mg of peanut protein without moderate to severe allergic symptoms, compared with 5% of those given placebo. The 600 mg is an amount equivalent to approximately 2 1/2 peanuts or half a teaspoon of regular peanut butter.
In addition, significantly higher proportions of participants treated with Xolair compared with placebo tolerated at least 1,000 mg of protein from milk, egg or cashew without moderate to severe allergic symptoms, according to the release.
Xolair is the first and only FDA-approved medicine to reduce allergic reactions in people with one or more food allergies, per the release.
Roche added that detailed results and analysis from OUtMATCH are expected to be presented at the 2024 American Academy of Allergy, Asthma & Immunology Annual Meeting on Feb. 25.
“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,” Levi Garraway, MD, PhD, Roche chief medical officer and head of global product development, said in the release. “We look forward to bringing this treatment to the food allergy community who have long awaited an advancement.”