Xolair Gets Breakthrough Therapy Designation from US FDA for Treatment of Food Allergies

If approved, the drug would be the first FDA-approved treatment for the prevention of severe reactions due to food allergies.

Food allergies can be life-threatening and result in an estimated 200,000 emergency room visits each year, according to Genentech, a member of the Roche Group. Notably, as many as 8% of children (6 million) and 4% of adults (9 million) in the US are affected by food allergies, and those numbers are growing. To date, however, no drug has been approved by the US Food and Drug Administration (FDA) for the prevention of severe reactions due to food allergies.

Genentech, in collaboration with Novartis Pharmaceuticals Corporation, is working to change that with the development of Xolair® (omalizumab). The company recently received a Breakthrough Therapy Designation for Xolair® from FDA for the prevention of severe allergic reactions following accidental exposure to one or more foods in people with allergies.

The designation was granted based on the results obtained for seven clinical studies conducted over the last 10 years assessing the efficacy and safety of Xolair against peanut, milk, egg and other food allergens. Xolair was investigated as a monotherapy or in combination with an oral immunotherapy (OIT). The studies were supported by Genentech and the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institutes of Health (NIH).

Going forward, Genentech and Novartis Pharmaceuticals Corporation, in conjunction with NIAID and the Consortium of Food Allergy Research (CoFAR), will conduct a further study evaluating the efficacy and safety of Xolair in multiple food allergies.

Xolair is a monoclonal antibody formulated as an injectable prescription medicine with FDA approval for the treatment of moderate to severe persistent asthma in patients six years of age who do not respond to inhaled corticosteroids; or for those with chronic idiopathic urticaria (CIU; chronic hives without a known cause) in patients 12 years of age and older, that do not benefit from H1 antihistamine treatment.




Nigel Walker

Mr. Walker is the founder and managing director of That’s Nice LLC, a research-driven marketing agency with 20 years dedicated to life sciences. Nigel harnesses the strategic capabilities of Nice Insight, the research arm of That’s Nice, to help companies communicate science-based visions to grow their businesses. Mr. Walker earned a bachelor’s degree in graphic design with honors from London College of Communication, University of the Arts London, England.