New Drug to Prevent Severe Food Allergies Gets FDA Approval

By Trisha Andrada

Feb 20, 2024 08:24 AM EST

The US Food and Drug Administration (FDA) gave its approval to a new drug that could completely transform the lives of those with severe food allergies.

According to the New York Post, the FDA authorized on Friday omalizumab, better known as Xolair, that can help lessen the severity of food allergies in both adults and children older than one, including lowering the risk of anaphylaxis or a severe, life-threatening allergic reaction in the event of unintentional exposure. 

However, the drug is not recommended to be used during an allergic reaction. Instead, it should be administered every two to four weeks to gradually lower the likelihood of future reactions.

Epinepherine Auto-Injectors with Teal Background
(Photo : Pixelumina Photography on Unsplash)

Xolair Is First FDA-Approved Medication to Reduce Allergic Reactions Over Time

In a statement, the FDA said, "Xolair is the first FDA-approved medication to reduce allergic reactions to more than one type of food after accidental exposure." However, the FDA warned that patients using the medication should still avoid the foods to which they are sensitive.

Kelly Stone, MD, PhD., associate director of the Division of Pulmonology, Allergy, and Critical Care in the FDA's Center for Drug Evaluation and Research, clarified in the statement that "while it will not eliminate food allergies or allow patients to consume food allergens freely, its repeated use will help reduce the health impact if accidental exposure occurs."

At this time, the only known way to manage food allergies is to completely cut out that particular food item from a person's meals, and in extreme cases, epinephrine may be administered right away.

Among the conditions that Genentech-developed Xolair has been previously authorized to treat include moderate to severe persistent allergic asthma, chronic hives, chronic inflammatory sinus illness accompanied by nasal polyps, and chronic hives.

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Xolair Drug's Effectiveness

According to research funded by the National Institute of Allergy and Infectious Diseases, some individuals have reported an improvement in their tolerance to food allergies after taking Xolair. 

Compared to a placebo, the study showed that Xolair has dramatically increased the percentage of 1-year-old children with food allergies who were able to tolerate small quantities of peanut, milk, egg, and cashew without experiencing an allergic reaction.

However, side effects such as fever and injection site reactions were observed in most of those who took the Xolair injection.

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