The FDA has granted Breakthrough Therapy designation to omalizumab (Xolair, Genentech), a subcutaneous injection therapy indicated for atopic conditions which could become the first treatment approved for the prevention of severe food allergy reactions.
Omalizumab was granted the designation to expedite its regulatory development and review as a potential therapy for serious or life-threatening conditions. The designation was based on data from 7 clinical trials over the past decade, which assessed omalizumab’s efficacy and safety versus various food allergens, such as peanut, milk, and egg.
The trials, which assessed omalizumab as both a monotherapy or in combination with oral immunotherapy, were supported by both Genentech and individual sponsors, such as the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH). Genentech and Novartis Pharmaceuticals are currently working with the NIAID and the Consortium of Food Allergy Research to launch a potentially pivotal study assessing the efficacy and safety of omalizumab in multiple food allergies, with details coming at a later date.
Omalizumab was previously approved by the FDA to treat moderate to severe persistent asthma in patients aged 6 years or older whose asthma symptoms are not controlled by inhaled corticosteroids, as well as chronic idiopathic urticaria in patients 12 years and older who continue to have hives that are not controlled by H1 antihistamine treatment.
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Dr. Kenneth Backman of Allergy and Asthma Care of Fairfield County comments: "This is incredibly exciting news for food allergy sufferers. Up until now, avoidance has been the only treatment proven safe and effective for preventing allergic reactions to food. While oral immunotherapy is being studied, it is still considered experimental and not recommended by food allergy researchers or allergy societies. Xolair offers the ability to reduce the likelihood of severe allergic reactions to foods without the risk associated with ingesting the food allergen daily, as is done in oral immunotherapy, which often triggers reactions including anaphylaxis, and carries the risk of complications such as eosinophilic esophagitis. We are hopeful that Xolair will obtain rapid approval for use in food allergies, and look forward to the protection and relief it will provide to countless patients."