Living with food allergies can be difficult. There is no cure, and standard management is to always be careful about everything you eat and keep an emergency injection of epinephrine on hand in case a quick and life-threatening reaction occurs due to accidental ingestion. But for the millions of people in the United States who live with such allergies, a new drug could ease the threat.
On Friday, the Food and Drug Administration Approval of antibody drug omalizumab (product name Xolair) As an injection to reduce allergic reactions to food in people over 1 year of age. In a study of 168 children and adults with multiple food allergies, participants who received omalizumab injections for 16 to 20 weeks experienced a lower allergy challenge at the end of the study dose than participants who received a placebo. They were much more likely to tolerate sexual foods.
Omalizumab, previously approved to treat asthma, hives and nasal polyps, works by binding to a class of antibodies in the body called immunoglobulin E (IgE), which are specifically involved in allergic reactions. The monoclonal antibody drug binds to her IgE and blocks it from binding to target receptors, preventing it from triggering the immune response that causes allergic symptoms.
“This newly approved use of Xolair provides a treatment option that reduces the risk of adverse allergic reactions in certain patients with IgE-mediated food allergies,” the FDA’s Department of Respiratory Medicine and Allergy said. -Kelly Stone, Associate Director of Critical Care. The Center for Pharmaceutical Evaluation and Research said in a statement today. “Although it does not eliminate food allergy or give patients free access to food allergens, repeated use can help reduce the health effects of accidental exposure. .”
trial It began in 2019, is run by the National Institute of Allergy and Infectious Diseases, and is still ongoing.but interim analysis Early data was enough to convince the FDA of the drug’s benefits.
More tolerance
For the study, researchers recruited people with at least two other food allergies in addition to peanuts, including milk, egg, wheat, cashews, hazelnuts, and walnuts. Those assigned to receive omalizumab received injections every two to four weeks for 16 to 20 weeks. The researchers then tested whether participants could consume more than 600 milligrams of peanut protein. This is equivalent to eating about 2.5 peanuts or more. Of those vaccinated, 68 percent (75 of 110 subjects) coped with peanut administration without exhibiting moderate to severe allergy symptoms, such as generalized hives, persistent cough, or vomiting. did. In the placebo group, only 6% (3 of 55 subjects) were able to manage this.
In a secondary study, the researchers tested other allergy-causing foods at higher doses of more than 1,000 milligrams. For cashews, 42 percent (27 of 64) of participants receiving omalizumab withstood the challenge without experiencing a moderate or severe allergic reaction, compared with 3 percent (30 of 30) of participants in the placebo group. 1 person). Regarding milk, 66 percent (25 of 38 subjects) of subjects who received the drug showed tolerance to dairy products, compared to only 11 percent (19 subjects) in the placebo group. 2 middle school students). For eggs, 67 percent (31 of 46 subjects) who received the drug tolerated the dose, compared with 0 percent of 19 subjects who received a placebo.
The benefits of omalizumab were not universal. The FDA notes that 17 percent of people who received the drug did not significantly improve their sensitivity to the food that caused their allergy. Therefore, the FDA warns that even if you are given Xolair, you should avoid foods that cause allergies.
The trial is ongoing, but researchers plan The duration of the drug’s effect and whether it can be combined with another strategy to gradually reduce food allergies, namely oral immunotherapy (OIT), which uses a small amount of allergen each day to build tolerance over time. This is to consider what to do. To test longevity, some trial participants will receive the injection for an additional 24 weeks, followed by an additional food challenge to see if the drug remains useful in relieving allergic reactions over time. Masu. During the OIT portion of the trial, participants will receive an additional 16 weeks of injections, during which some participants will receive OIT with multiple allergens. Follow-up will then take place for an additional 44 weeks.
The FDA says the most common side effects of omalizumab are injection site reactions and fever, but the agency also notes the potential for joint pain, rash, parasitic infections, malignancy, and abnormal laboratory test results. I’m warning you.
