Omalizumab, an anti-immunoglobulin E antibody, is approved by the Food and Drug Administration for three indications:
- Moderate to severe persistent asthma in patients aged 6 years and older.
- Chronic idiopathic urticaria in adults and adolescents aged 12 years and older.
- Chronic rhinosinusitis with nasal polyps in adult patients aged 18 years and older.
Currently, the FDA is reviewing the biologics license application for omalizumab for the reduction of allergic reactions that may occur with accidental exposure in patients aged 1 year and older with food allergies.
According to the data from the phase 3 National Institute of Allergy and Infectious Diseases trial, omalizumab significantly increased the amounts of multiple common foods that food-allergic children and adolescents could consume without an allergic reaction.
The first stage of the study was designed to assess the efficacy of omalizumab in increasing the amount of food it takes to cause an allergic reaction, thereby reducing the likelihood of reactions to small amounts of food allergens in the event of accidental exposure. The study team enrolled children and adolescents ages 1 to 17 years and three adults ages 18 to 55 years, all with confirmed allergy to peanuts and at least two other common foods (including milk, egg, wheat, cashew, hazelnut, or walnut). Patients were randomly assigned to receive omalizumab injections or placebo for 16 to 20 weeks.
The study’s independent Data and Safety Monitoring Board (DSMB) examined data on the first 165 children and adolescents who participated in the first stage of the trial. The DSMB found that participants who received omalizumab injections could consume higher doses of peanut, egg, milk, and cashew without allergic reactions than participants who received placebo injections.
If FDA approved, omalizumab would be the first medicine that reduces allergic reactions to multiple foods after accidental exposure. However, the company cautioned, patients with these allergies would still need to avoid the foods that they are allergic to when taking omalizumab.
