The FDA has granted approval for the first medication capable of mitigating the severity of multiple food allergies simultaneously. Individuals with severe allergies to common foods such as milk, peanuts, and shellfish now have a novel method to mitigate potentially life-threatening reactions following inadvertent exposure.
Xolair, known by its generic name omalizumab, has received FDA authorization for the treatment of multiple severe food allergies, as announced by the U.S. Food and Drug Administration on Friday, February 16. This injectable medication is classified as a monoclonal antibody, containing synthetic proteins engineered to target specific receptors within the body. Upon administration, Xolair binds to immunoglobulin E (IgE), a type of naturally occurring antibody primarily responsible for triggering allergic responses.
Numerous food allergies stem from IgE-mediated reactions, encompassing sensitivities to milk, eggs, soy, peanuts, tree nuts, fish, shellfish, and wheat. Notably, Xolair, previously sanctioned for addressing other medical conditions such as allergic asthma, can now serve as a safeguard against allergic reactions triggered by various food allergens.
Dr. Kelly Stone, Associate Director of the Division of Pulmonology, Allergy, and Critical Care within the FDA’s Center for Drug Evaluation and Research, underscored the significance of this new approval. While Xolair does not eradicate food allergies or enable unrestricted consumption of allergenic foods, its recurrent administration offers a means to mitigate the health consequences of accidental exposure.
It is imperative to note that Xolair does not replace epinephrine injections, notably EpiPen devices, crucial for counteracting life-threatening systemic allergic reactions known as anaphylaxis. While EpiPen injections swiftly dilate airways and stabilize blood pressure during allergen exposure, Xolair operates preventively, administered every two to four weeks to facilitate allergen tolerance and diminish reaction severity upon exposure.
Dosage and injection frequency of Xolair are tailored to individual body weight and IgE levels, administered either by healthcare professionals or self-injection at home under appropriate clinical supervision.
Clinical trials involving nearly 170 participants, encompassing adults and children over one year old with confirmed allergies to peanuts and at least two other foods, demonstrated promising outcomes. Those treated with Xolair exhibited a notable improvement, with 68% achieving the ability to tolerate a dose of peanut protein without experiencing moderate to severe symptoms compared to only 6% in the placebo group. Similar efficacy was observed regarding reactions to cashews, milk, and eggs.
However, it is important to acknowledge that a substantial proportion (17%) of individuals administered Xolair experienced no discernible improvement in peanut tolerance, necessitating continued adherence to allergen avoidance measures despite treatment.
Common side effects of Xolair include fever and localized reactions at the injection site, with potential adverse effects including fever, joint pain, rashes, and parasitic infections. Given IgE’s role in parasite defense, blocking these antibodies may elevate susceptibility to such infections.
The FDA advises initial administration of Xolair in a healthcare setting due to reported cases of anaphylaxis shortly after drug administration. While Xolair was previously prescribed off-label for food allergies, its official approval is expected to facilitate broader access, albeit at a cost ranging from $2,900 to $5,000 per month, with varying out-of-pocket expenses for insured patients.
This article serves as informational and does not constitute medical advice.
