In a groundbreaking development for children suffering from severe food allergies, the Food and Drug Administration (FDA) has approved a new drug that shows promise in protecting them from potentially life-threatening reactions.
Xolair (omalizumab) injection, which is now FDA-approved, has been shown to reduce allergic reactions, including the risk of anaphylaxis, in some adults and children aged one year and older.
According to data from the CDC's National Center for Health Statistics, nearly one-third of adults and more than one-fourth of children in the United States reported having a seasonal allergy, eczema, or food allergy in 2021.
Twenty-seven percent of children and 31.8% of adults experience allergy symptoms, totaling more than 100 million people.
How Effective Is the New Drug?
A recent study published in The New England Journal of Medicine, led by Dr. Robert A. Wood of the Johns Hopkins Children's Center, highlights Xolair's effectiveness in reducing the risk of serious allergic reactions in children and adolescents with severe food allergies.
The study included 177 participants who were allergic to peanuts and at least two other foods. The results showed a significant reduction in life-threatening reactions, such as anaphylaxis, in children exposed to trace amounts of peanuts, cashews, milk, and eggs.
Notably, Xolair is the first FDA-approved medication capable of reducing allergic reactions to multiple types of food allergens, representing a significant advancement in allergy treatment.
One downside is that the medication is administered via injection every two to four weeks, which can be challenging for many people, especially children who are afraid of needles.
How the Drug Works
Xolair works by binding to immunoglobulin E (IgE), the antibody that causes allergic reactions, and inhibiting its effects, thereby reducing the severity of allergic reactions in people with food allergies. However, it should be noted that Xolair is not a cure for food allergies and does not eliminate the need for strict allergen avoidance.
Throughout the study mentioned above, participants who received Xolair injections every two to four weeks for 16 to 20 weeks demonstrated greater tolerance to trace amounts of food allergens than those who received placebos. While the drug had a good safety profile, common side effects included injection site reactions and fevers.
According to the FDA, patients should not take Xolair if they have a history of severe hypersensitivity to Xolair or any of its components. Also, Xolair is not approved for immediate emergency treatment of allergic reactions, such as anaphylaxis - emphasizing the importance of being prepared and having access to epinephrine.
The FDA's approval of Xolair marks a new era in allergy treatment, providing hope to millions of children and adults dealing with food allergies.
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