On February 16, 2024, the US Food and Drug Administration (FDA) approved omalizumab to reduce allergic reactions, including anaphylaxis, that may occur with accidental exposure in patients aged 1 year and older with immunoglobulin E-mediated food allergy.
Omalizumab is a prescription biologic medicine that is given as an injection under the skin. It reduces the release of mediators throughout the allergic inflammatory cascade by targeting and blocking immunoglobulin E (IgE). Omalizumab dose and dosing frequency are determined by total serum IgE level and body weight. The recommended Omalizumab dosage for treatment of food allergy is 75 mg to 600 mg once every 2 or 4 weeks.
The FDA approval is based on data from the National Institutes of Health -sponsored Phase III study. The study evaluated Omalizumab safety and efficacy 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. Patients entered the study unable to tolerate up to 100 mg of peanut protein (equivalent to about one third of a peanut), and up to 300 mg each of milk, egg, and cashew protein. Patients were randomized to receive placebo or Omalizumab either every two weeks or every four weeks for 16 to 20 weeks. After 16 to 20 weeks, each participant completed four food challenges, receiving gradually increasing amounts of peanut protein, two other food proteins they were allergic to, and a placebo ingredient. The food challenges were conducted to assess patients’ ability to consume a single dose of at least 600 mg of peanut protein (equivalent to approximately two and a half peanuts or half a teaspoon of regular peanut butter), and a single dose of at least 1,000 mg of milk, egg or cashew protein (equivalent to approximately two tablespoons of milk, one-quarter of an egg or three and a half cashews) without experiencing moderate to severe allergic symptoms.
Study results showed 68% of patients treated with Omalizumab for 16 to 20 weeks tolerated at least 600 mg of peanut protein without moderate to severe allergic symptoms, compared to 5% of those treated with placebo. In addition, a statistically significant higher proportion of patients treated with Omalizumab compared to placebo tolerated at least 1,000 mg of protein from milk (66%), egg (67%) or cashew (42%) without moderate to severe allergic symptoms. Safety findings were consistent with the known safety profile of Omalizumab. The most common adverse events in Omalizumab -treated patients (≥3% of patients) in the study were injection site reaction and fever.
Omalizumab offers many children and adults a new way to help manage their food allergies and reduce allergic reactions that can result from exposure to food allergens. But patients who take omalizumab to treat food allergies should continue to avoid all foods to which they are allergic because omalizumab helps reduce symptoms and it is not a cure for food allergies. Also, Omalizumab should not be used for the emergency treatment of any allergic reactions, including anaphylaxis, so patients should continue to carry their epinephrine auto-injector with them at all times and not neglect to carry it during treatment with omalizumab.
We are awaiting the third phase of the study, which will end at the end of 2025, to know more information about the duration of use of it and its continuity.
