medicine
Published February 19, 2024, 4:19 p.m. ET
The Food and Drug Administration on Friday gave the green light to a new drug that could be life-changing for people with severe food allergies.
Xolair, or omalizumab, has been approved to reduce severe allergic reactions to certain foods in adults and children over one year of age, including reducing the risk of anaphylaxis, which can occur with accidental exposure.
However, the medication is not intended for use in an allergic reaction – it is intended to be given repeatedly every two to four weeks to reduce the risk of future reactions over time.
The FDA has approved Xolair, or omalizumab, to reduce severe allergic reactions to certain foods. Xolair
However, the FDA also noted that patients taking Xolair – considered “the first and only drug approved by the FDA to reduce allergic reactions in people with one or more food allergies” – must continue to avoid foods to which they are allergic .
“This newly approved use of Xolair will provide a treatment option to reduce the risk of harmful allergic reactions in certain patients with IgE-mediated food allergies,” says Kelly Stone, MD, Ph.D., associate director of the Division of Pulmonology, Allergy and Intensive care at the FDA's Center for Drug Evaluation and Research, a statement said.
“Although this will not eliminate food allergies or allow patients to freely consume food allergens, repeated use will help reduce health effects if accidental exposure occurs.”
There is currently no cure for food allergies, and the only known treatment is strict avoidance of food and immediate administration of epinephrine in an immediate emergency.
The injection, developed by Genentech, has already been approved to treat some cases of moderate to severe persistent allergic asthma, as well as some cases of chronic hives and chronic inflammatory sinus disease with nasal polyps.
An estimated 20 million Americans suffer from food allergies. The most common are shellfish, milk, eggs, fish, peanuts, tree nuts, sesame, soy and wheat. Getty Images/iStockphoto
A study sponsored by the National Institute of Allergy and Infectious Diseases found that Xolair helped some people tolerate foods they were allergic to over time.
The study showed that compared to a placebo, a significantly higher proportion of patients as young as one year old with food allergies treated with Xolair were able to tolerate small amounts of peanut, milk, egg and cashew without an allergic reaction.
The most common side effects seen in patients taking Xolair were injection site reactions and fever.
Xolair is considered “the first and only FDA-approved drug to reduce allergic reactions in people with one or more food allergies.” Xolair
“Xolair offers patients and families an important new treatment option that can help redefine the way food allergies are managed and reduce the often serious allergic reactions that can result from exposure to food allergens,” says Levi Garraway, M.D., Ph.D., Genentech's chief medical officer and head of global product development said in a statement.
“Today’s approval is based on 20 years of patient experience and an established efficacy and safety profile since the initial approval of Xolair in allergic asthma. We look forward to bringing this treatment to the food allergy community, which has long awaited further development.”
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