Genentech announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for Xolair (omalizumab) for the prevention of severe allergic reactions following accidental exposure to 1 or more foods in patients with allergies.
Xolair, an anti-IgE antibody, is currently approved to treat moderate to severe persistent asthma in patients ≥6 years of age with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids. It is also indicated to treat chronic idiopathic urticaria (CIU) in patients ≥12 years of age who remain symptomatic despite H1 antihistamine treatment.
The FDA designation was supported by data from 7 studies evaluating the safety and efficacy of Xolair against various food allergens (eg, peanut, milk, egg, others). In these studies, Xolair was assessed as monotherapy or in combination with oral immunotherapy. A potentially pivotal study evaluating Xolair in the treatment of multiple food allergies is also being planned by Genentech, Novartis, the National Institute of Allergy and Infectious Diseases (NIAID), and the Consortium of Food Allergy Research (CoFAR); the details of this study will be released at a later time.
Xolair is available as 150mg strength powder for subcutaneous injection after reconstitution in single-use vials.
For more information call (800) 821-8590 or visit Xolair.com.