The FDA has broadened the scope of Xolair, a medication used for asthma, to now include treatment for severe food allergies.
The U.S. Food and Drug Administration announced on Friday that a medication typically prescribed for asthma can now be utilized to assist individuals with food allergies in preventing severe reactions.
The medication omalizumab, sold under the brand name Xolair, was granted approval to decrease allergic responses triggered by accidental ingestion of food. People as young as 1 year old with allergies can receive the medication through an injection every 2-4 weeks, depending on their weight and how their body responds to allergens.
Approximately 17 million individuals in the United States are affected by a specific type of food allergy that can lead to quick and severe symptoms, such as life-threatening whole-body reactions.
Individuals taking Xolair should still refrain from consuming trigger foods like peanuts, cashews, hazelnuts, walnuts, dairy, and eggs. This treatment enables them to handle larger quantities of these foods without experiencing severe reactions.
Numerous individuals who have allergies, as well as their loved ones, experience ongoing apprehension over being exposed to allergens and frequently refrain from eating out and participating in social events.
Dr. Robert Wood, director of the pediatric allergy division at Johns Hopkins Children’s Center, expressed that having this protection will have a significant impact on people’s lives.
The FDA’s determination was influenced by research conducted by Wood and supported by the National Institutes of Health, which demonstrated that Xolair enabled approximately 68% of individuals with peanut allergies to withstand about 600 milligrams (equivalent to 1/2 teaspoon) of peanut protein. In comparison, only about 6% of those who received placebo injections were able to do the same.
According to a summary of a study, the findings were comparable for various allergens, including tree nuts, milk, egg, and wheat. The complete results will be presented at a conference and released in a peer-reviewed publication later this month.
Wood predicted that between 25% and 50% of individuals who have food allergies, specifically kids and young adults, would choose to utilize Xolair.
Dr. Ruchi Gupta, director of the Center for Food Allergy & Asthma Research at Northwestern University, stated that the medication has been utilized for off-label treatment of food allergies. She supports the product’s complete approval.
Xolair is a form of medication known as a monoclonal antibody, which functions by inhibiting the body’s innate reaction to allergens. It received initial approval in 2003 and has been effectively utilized in managing asthma, nasal polyps, and chronic hives. It is manufactured by Novartis and Roche, and is marketed by a subsidiary of Roche, Genentech.
The primary adverse reactions to Xolair are typically injection site responses and fever, however, the FDA has acknowledged that the medication has also been linked to joint discomfort, skin irritation, parasitic infections, cancerous growths, and irregular laboratory findings. Xolair includes a cautionary warning stating that the treatment may trigger anaphylaxis and should only be initiated in a medical facility prepared to handle such a reaction.
The medication is not authorized for immediate relief of allergic responses.
According to Genentech, the cost of Xolair varies from $2,900 per month for children to $5,000 per month for adults. However, the out-of-pocket expenses for insured patients are usually lower than this amount.
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