FILE - This Feb. 20, 2015 photo shows an arrangement of peanuts in New York. Xolair, the brand name for the drug omalizumab, used to treat asthma can now be used to help people with food allergies avoid severe reactions, the U.S. Food and Drug Administration said Friday, Feb. 16, 2024. (AP Photo/Patrick Sison, File)
The U.S. Food and Drug Administration announced on Friday that Xolair, known as omalizumab in its generic form, has gained approval as the first medication to mitigate allergic reactions triggered by accidental exposure to food allergens. This breakthrough offers hope to millions in the U.S. grappling with severe food allergies, which can lead to life-threatening reactions.
Xolair, typically prescribed for asthma treatment, now extends its application to help individuals aged 1 and above manage food allergies through regular injections every two to four weeks, tailored to their weight and body's response to allergens.
Approximately 17 million Americans contend with food allergies capable of inducing rapid and severe symptoms, posing serious health risks. While Xolair doesn't eliminate the need to avoid trigger foods like peanuts, cashews, and eggs, it enables patients to tolerate higher doses of these allergens without experiencing severe reactions.
For many allergy sufferers and their families, the fear of accidental exposure to allergens pervades daily life, often prompting avoidance of social situations and dining out. Dr. Robert Wood, overseeing the pediatric allergy division at Johns Hopkins Children’s Center, hailed the FDA's decision as potentially life-changing for affected individuals.
The FDA's approval stems from a study spearheaded by Dr. Wood and backed by the National Institutes of Health. Findings revealed that Xolair enabled about 68% of participants with peanut allergies to tolerate up to 600 milligrams of peanut protein, compared to a mere 6% among those receiving placebo injections. Similar outcomes were observed with other allergens such as tree nuts, milk, egg, and wheat.
Dr. Ruchi Gupta, leading the Center for Food Allergy & Asthma Research at Northwestern University, celebrated the medication's full approval, emphasizing its previous off-label use in treating food allergies.
Xolair, classified as a monoclonal antibody treatment, operates by obstructing the body's natural response to allergens. Initially sanctioned in 2003, it has been instrumental in managing asthma, nasal polyps, and chronic hives. Manufactured by Novartis and Roche, Xolair is distributed by Roche's subsidiary, Genentech.
While Xolair offers a promising solution, it comes with potential side effects including injection site reactions, fever, joint pain, rash, and susceptibility to certain infections and malignancies. Notably, the medication's administration can trigger anaphylaxis, necessitating initiation in a healthcare setting prepared to manage such reactions.
Xolair, however, is not intended for emergency allergy treatment. Despite its considerable list price ranging from $2,900 to $5,000 monthly, most insured patients typically bear lower out-of-pocket costs, according to Genentech.
