FDA Approves First Medication to Help Reduce Allergic Reactions to Multiple Foods After Accidental Exposure

Main Points

FDA approval of Xolair for food allergy management.

The FDA approved Xolair (omalizumab) injection for reducing allergic reactions including anaphylaxis in certain adults and children aged 1 year or older after accidental exposure to food allergens. Xolair is intended for repeated use and not for emergency treatment.

Xolair: first drug for multi-food allergy reduction.

Originally approved in 2003 for allergic asthma, Xolair is now the first drug to be FDA-approved for reducing allergic reactions to multiple foods.

Mechanism and precautions of Xolair.

Xolair binds to IgE, blocking it from triggering allergic reactions. It comes with a boxed warning for anaphylaxis and other side effects like fever and joint pain.

Study results prove Xolair's efficacy.

In a key study, 68% of Xolair-treated subjects were able to eat peanut protein without severe allergic reactions, showing its efficacy.

Insights

FDA approves Xolair for IgE-mediated food allergy in adults and children 1 year or older to reduce allergic reactions after accidental food exposure.

Today, the U.S. Food and Drug Administration approved Xolair (omalizumab) injection for immunoglobulin E-mediated food allergy in certain adults and children 1 year or older for the reduction of allergic reactions (Type I), including reducing the risk of anaphylaxis, that may occur with accidental exposure to one or more foods. Patients who take Xolair must continue to avoid foods they are allergic to. Xolair is intended for repeated use to reduce the risk of allergic reactions and is not approved for the immediate emergency treatment of allergic reactions, including anaphylaxis.

Xolair's efficacy proven in a multi-center, double-blind, placebo-controlled study involving subjects allergic to peanut and at least two other foods.

Xolair’s safety and efficacy in reducing allergic reactions in subjects with food allergies was established in one multi-center, double-blind, placebo-controlled study of 168 pediatric and adult subjects (at least 1 year of age or older) who were allergic to peanut and at least two other foods, including milk, egg, wheat, cashew, hazelnut or walnut. Researchers randomly gave subjects either Xolair or placebo treatment for 16 to 20 weeks.

68% of Xolair-treated subjects could consume peanut protein without moderate to severe allergic symptoms.

Of those who received Xolair, 68% (75 of 110 subjects) were able to eat the single dose of peanut protein without moderate to severe allergic symptoms (e.g., whole body hives, persistent coughing, vomiting), compared to 6% (3 of 55 subjects) who received placebo; these results are statistically significant and clinically meaningful for subjects with food allergy.

Xolair also showed efficacy for allowing the consumption of cashew, milk, and egg protein without severe allergic reactions.

The key secondary measures of efficacy were the percentage of subjects who were able to consume a single dose (1,000 milligrams or greater) of cashew, milk or egg protein without moderate to severe allergic symptoms at the end of the 16-to-20-week treatment course. For cashew, 42% (27 of 64 subjects) who received Xolair achieved this endpoint compared to 3% (1 of 30 subjects) who received placebo. For milk, 66% (25 of 38 subjects) who received Xolair achieved this endpoint, compared to 11% (2 of 19) who received placebo. For egg, 67% (31 of 46 subjects) who received Xolair achieved this endpoint, compared to 0% of the 19 who received placebo.

URL

https://www.fda.gov/news-events/press-announcements/fda-approves-first-medication-help-reduce-allergic-reactions-multiple-foods-after-accidental

Tags