“Food allergies can have a significant impact on the lives of children and adults, and they are a growing public health concern for which there are currently no FDA-approved treatments,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “We are committed to helping address this high unmet medical need and look forward to working with leaders in the field to further develop Xolair as a potential medicine to help people with this condition that can be life-threatening.”

Food allergies can be life-threatening, and result in an estimated 200,000 emergency room visits each year. Up to 8 percent of children and 4 percent of adults in the U.S. are affected by food allergies, and the incidence is increasing.

Breakthrough Therapy Designation was granted on the basis of data from seven clinical studies over the last decade assessing the efficacy and safety of Omalizumab against a range of food allergens including peanut, milk, egg and others. These studies of Omalizumab, as monotherapy or in combination with oral immunotherapy (OIT), were supported by Genentech and independent sponsors including the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).This has been now approved by FDA.

Genentech and Novartis Pharmaceuticals Corporation are working closely with NIAID and the Consortium of Food Allergy Research (CoFAR) to initiate a potentially pivotal study evaluating the efficacy and safety of Omalizumab in multiple food allergies and will disclose details at a later date.

Xolair for subcutaneous use is an injectable prescription medicine approved by the FDA to treat.Moderate to severe persistent asthma in patients six years of age or older whose asthma symptoms are not controlled by asthma medicines called inhaled corticosteroids. A skin or blood test is performed to see if a patient has allergies to year-round allergens.Chronic idiopathic urticaria (CIU; chronic hives without a known cause) in patients 12 years of age and older who continue to have hives that are not controlled by H1 antihistamine treatment.Xolair is not used to treat other allergic conditions, other forms of urticaria, acute bronchospasm or status asthmaticus.

The most important information patients should know about Omalizumab is that a severe allergic reaction called anaphylaxis can happen when a patient receives it. The reaction can occur after the first dose, or after many doses. wheezing, shortness of breath, cough, chest tightness or trouble breathing,dizziness,tachycardia
low blood pressure, anxiety,flushing, itching, hives or feeling warm,swelling of the throat or tongue.

    Omalizumab should be given by a healthcare provider, in a healthcare setting.Xolair is given in one or more injections under the skin (subcutaneous), 1 time every two or four weeks.In asthma patients, a blood test for a substance called IgE must be performed prior to starting it to determine the appropriate dose and dosing frequency.