WASHINGTON (AP) – The Food and Drug Administration has approved a new drug that could potentially be life-changing for individuals with severe food allergies. The drug, known as Xolair or omalizumab, has been given the green light to help reduce severe allergic reactions to certain foods in both adults and children over the age of 1, with the aim of lowering the risk of anaphylaxis that may occur with accidental exposure.
However, it’s important to note that Xolair is not intended to be used during an allergic reaction, but rather as a preventive measure. Patients are advised to administer the medication repeatedly every two to four weeks in order to reduce the risk of future reactions over time.
Although the drug provides a treatment option to reduce the risk of harmful allergic reactions among certain patients with IgE-mediated food allergies, it does not eliminate food allergies entirely or allow patients to freely consume food allergens. The FDA emphasized the importance of continuing to avoid foods that patients are allergic to, despite taking Xolair.
According to Dr. Kelly Stone, the associate director of the Division of Pulmonology, Allergy, and Critical Care in the FDA’s Center for Drug Evaluation and Research, the newly approved use for Xolair will offer a treatment option to reduce the risk of harmful allergic reactions among certain patients with IgE-mediated food allergies.
It’s worth noting that there is currently no cure for food allergies, with strict avoidance of the allergenic food and immediate use of epinephrine being the only known treatment. Xolair, developed by Genentech, has previously been approved to treat cases of moderate-to-severe persistent allergic asthma, chronic hives, and chronic inflammatory sinus disease with nasal polyps.
A study sponsored by the National Institute of Allergy and Infectious Diseases found that Xolair has enabled some individuals to tolerate foods they are allergic to over time. The study revealed that a higher proportion of patients treated with Xolair were able to withstand small amounts of peanut, milk, egg, and cashew without experiencing an allergic reaction, compared to those who received a placebo.
Dr. Levi Garraway, Genentech’s chief medical officer and the head of Global Product Development, expressed the impact of the FDA’s approval, emphasizing that Xolair presents an important new treatment option that can redefine the way food allergies are managed and reduce the often serious allergic reactions resulting from exposure to food allergens.