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FDA grants Xolair breakthrough therapy label for food allergies

The FDA granted breakthrough therapy designation to the injectable prescription medicine Xolair for preventing severe allergic reactions after accidental exposure to one or more foods in those with allergies, the manufacturer of the drug announced in a press release.

“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,” Sandra Horning, MD, chief medical officer and head of global product development at Genentech, said in the release.

“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.”

According to Genentech, breakthrough therapy designation was granted on the basis of data from seven clinical studies involving Xolair (omalizumab; Genentech, Novartis) during the past 10 years that evaluated the efficacy and safety of the drug in a range of food allergens, including egg, milk and peanut, among others.

The company also stated that omalizumab for subcutaneous use has been approved by the FDA to treat moderate to severe persistent asthma in patients older than 6 years whose asthma symptoms are not controlled by inhaled corticosteroids and chronic idiopathic urticaria in patients older than 12 years who continue to have hives that are not controlled by H1-antihistamine treatment.

Genentech advised that patients may experience anaphylaxis at any time while taking the medication. Patients who take omalizumab and experience anxiety or feeling of “impending doom,” flushing, itching, hives or feeling warm swelling of the throat or tongue, throat, wheezing, shortness of breath, cough, chest tightness or trouble breathing, low BP, dizziness, fainting, rapid or weak heartbeat, tightness, hoarse voice or trouble swallowing should go to an ED immediately, as these may be signs of an allergic reaction, according to Genentech.

Disclosure: Horning is employed by Genentech.