The US 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, according to manufacturer Genetech.
Breakthrough Therapy Designation is designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases, and to help ensure people have access to them through FDA approval as soon as possible.
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, and chronic idiopathic urticaria (CIU) in patients 12 years of age and older who continue to have hives that are not controlled by H1 antihistamine treatment.
Food allergies can be life-threatening, and result in an estimated 200,000 emergency room visits each year. Up to 8% of children and 4% of adults in the US are affected by food allergies, and the incidence is increasing.
“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.”