Xolair for food allergies may become a treatment in the future as the FDA has granted Breakthrough Therapy Designation for Xolair. Xolair (omalizumab) would be used for the prevention of severe allergic reactions following accidental exposure to 1 or more foods in patients with allergies.
From the FDA; Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).
The FDA designation was supported by data from 7 studies evaluating the safety and efficacy of Xolair against various food allergens (peanut, egg, milk and others). Xolair was assessed in these studies as either monotherapy or used in a combination with oral immunotherapy. Genentech and Novartis are also planning on studying Xolair in the treatment of multiple food allergies with the National Institute of Allergy and Infectious Diseases (NIAD) and the Consortium of Food Allergy Research (CoFAR).
Currently Xolair has approval for the treatment of moderate to severe persistent asthma and chronic idiopathic urticaria. Xolair for food allergies could open up a new market for this IgE inhibitor. Food allergy reactions cause around 200,000 hospital visits each year in the U.S. alone, and up to 8% of children and 4% of adults are affected by them.
There have been a number of published studies looking at the use of Xolair by adding it to oral immunotherapy to induce tolerance to food allergens and improving its efficacy. Studies have shown adding Xolair and oral immunotherapy can induce much better tolerance than just using oral immunotherapy alone.
The breakthrough designation will allow the regulatory agency an expedited potential review of the medicine as a treatment for exposure to food allergens. There are currently no FDA approved treatments for food allergies. This is very exciting for food allergy sufferers as this may be the first medication approved for the treatment of food allergies.
Dr. Philip Hemmers, Chief of Allergy and Immunology at the highly regarded Allergy Center of Connecticut states, “This is exciting news for anxious patients and parents. As the number of children with food allergy has increased dramatically, the treatment options have remained stagnant. The experts can do no more than advise children on how to avoid foods and parents how to inject emergency medications for those inevitable reactions. Things are finally changing. Research centers and local offices are beginning to use oral immunotherapy. With use of omalizumab, we can more safely help those children at highest risk.”