Xolair, a 20-year-old asthma drug sold by Roche (ROG.S), and Novartis (NOVN.S), significantly reduced allergic reactions in people with multiple severe food allergies in a late-stage trial, researchers reported on Sunday (25/02/24) at a medical meeting.
Based on the results, presented at the American Academy of Allergy, Asthma & Immunology meeting in Washington, the U.S. Food and Drug Administration approved the drug earlier this month for adults and children age 1 year or older for reducing allergic reactions that may occur from accidental exposure.
Xolair, a monoclonal antibody known chemically as omalizumab, was first approved by the FDA in 2003 for treating asthma.
People using the drug will still need to avoid foods they are allergic to, but they can worry less about unknowingly consuming tiny bits of those foods, said study leader Dr. Robert Wood of Johns Hopkins Children's Center in Baltimore.
“There are a lot of patients and families for whom this will make a big difference in their lives,” Wood said.
The U.S. Department of Agriculture estimates that food allergies affect about 2% of U.S. adults and 4% to 8% of children. Each year, the most severe allergic reactions result in 30,000 emergency room visits, 2,000 hospitalizations, and 150 deaths.
The trial included 177 children ages 1 to 18 and three adults, all with severe food allergies.
At the start, participants reacted to less than 100 milligrams of peanut protein, the equivalent of about one-third of a peanut, and less than 300 mg of at least two other allergens, including milk, egg, cashew, walnut, hazelnut, and wheat.
Following treatment, 67% of participants who received omalizumab could consume the equivalent of about four peanuts without experiencing moderate to severe allergic reactions, compared to only 7% of patients who received a placebo.
Some 44% of those treated with the medicine could consume the equivalent of about 25 peanuts, researchers reported.
Patterns were similar when patients were challenged with the other foods.