In a significant development for individuals suffering from multiple food allergies, recent research has indicated that a drug, already approved for asthma and chronic hives, may offer protection against severe reactions to common allergens like peanuts, eggs, and milk. This revelation comes from an early analysis of data from a clinical trial supported by the National Institute of Allergy and Infectious Diseases (NIAID).Â
The drug in question, Xolair (omalizumab), developed by Genentech and Novartis, has been in use for treating allergic asthma and chronic hives. In the clinical trial, 165 children and adolescents who received injections of Xolair showed a remarkable ability to consume higher doses of allergenic foods without triggering an allergic reaction, compared to those treated with placebos. This finding was shared by Dr. Alkis Togias, chief of the allergy, asthma, and airway biology branch at NIAID.Â
Dr. Togias highlighted the dual benefits of Xolair: its ability to cover multiple food allergies and its well-established safety profile, given its two-decade presence in the market. The monoclonal antibody works by reducing allergic asthma attacks and hives, as demonstrated in previous clinical trials.Â
In a significant move, on December 19, the NIAID and Genentech announced that the Food and Drug Administration (FDA) was fast-tracking the approval of Xolair for use against accidental exposure to allergenic foods. While the drug is already FDA-approved for asthma, allowing it to be prescribed off-label, full FDA approval for food allergies would streamline insurance coverage and medical center clearances, which are currently challenging.Â
The cost of Xolair for allergic asthma is approximately $3,663 monthly, with an average treatment duration of about 10 months. For chronic spontaneous urticaria (chronic hives), the monthly cost varies between $1,323 and $2,646, depending on the dosage. Full FDA approval for food allergy treatment is expected to alleviate insurance hurdles, as noted by Dr. Togias.Â
Food allergies are a significant health concern in the U.S., affecting about 2% of adults and 4% to 8% of children, according to the USDA. Anaphylactic shock due to allergen consumption leads to thousands of emergency room visits, hospitalizations, and even deaths annually. Dr. Togias pointed out that approximately 40% of individuals with food allergies are allergic to multiple foods, underscoring the importance of a treatment like Xolair.Â
The clinical trial, detailed on clinicaltrials.gov, involved participants with peanut allergies and allergies to at least two other foods known to cause severe reactions, such as tree nuts, milk, and eggs. The trial included children and adolescents aged 1 to 17, along with three adults aged 18 to 55. The participants were tested with doses of peanut, egg, and milk proteins, both individually and in combination, to assess the drug’s efficacy.Â
Dr. Joyce Yu, a pediatric allergy and immunology expert at Columbia University, expressed optimism about the potential FDA approval of Xolair for food allergies, noting its convenience for both doctors and patients. Dr. Cosby Stone, an assistant professor in allergy and immunology at Vanderbilt University Medical Center, explained that Xolair works by suppressing IgE, a component of the immune system that overreacts to allergens.Â
The preliminary analysis of the trial showed that Xolair significantly increased the threshold for allergic reactions to peanuts, milk, eggs, and cashews in children and adolescents. Dr. Larry Tsai, from Genentech, emphasized the personal significance of these findings, as he and his child both suffer from severe food allergies.Â
The full trial results are expected to be published in a medical journal soon, with FDA approval potentially occurring in the first quarter of 2024. This development represents a major advancement in the management of food allergies, offering hope and relief to many families grappling with this challenging condition.Â
News Reference Â
New food allergies drug may prevent severe reactions to peanuts, egg and milk. (2023). Retrieved from https://www.nbcnews.com/health/kids-health/new-food-allergies-drug-may-prevent-severe-reactions-peanuts-egg-milk-rcna131194Â
