Posted by Michael Wonder on 14 Aug 2018
FDA grants breakthrough therapy designation for Xolair (omalizumab) for food allergies
12 August 2018 - There are currently no FDA approved treatments that help prevent severe reactions due to food allergies.
Genentech announced today that the U.S. FDA has granted breakthrough therapy designation for Xolair (omalizumab) for the prevention of severe allergic reactions following accidental exposure to one or more foods in people with allergies. This is the 23rd breakthrough therapy designation for Genentech’s portfolio of medicines.
Breakthrough therapy designation was granted on the basis of data from seven clinical studies over the last decade assessing the efficacy and safety of Xolair against a range of food allergens including peanut, milk, egg and others. These studies of Xolair, as monotherapy or in combination with oral immunotherapy, were supported by Genentech and independent sponsors including the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.
