Roche (SWX: ROG) has announced that the U.S. Food and Drug Administration (FDA) has granted a new indication for Xolair (omalizumab) to mitigate allergic reactions, including anaphylaxis, associated with IgE-mediated food allergies in both adult and pediatric patients aged 1 and older. While Xolair is designed to reduce the risk of such allergic reactions, patients are still advised to avoid specific food groups, and the drug is not intended for use in emergency situations like anaphylaxis.
The FDA’s approval is supported by data from the Phase III OUtMATCH study, which assessed Xolair in patients aged 1 to 55 who were allergic to peanuts and at least two additional food allergens, including milk, egg, wheat, cashew, hazelnut, and walnut. The trial included patients who could not tolerate up to 100 mg of peanut protein—equivalent to roughly one-third of a peanut—and up to 300 mg of milk, egg, and cashew protein. Following 16 to 20 weeks of treatment with either Xolair or placebo, participants underwent four food challenges, gradually receiving increasing amounts of their allergens to evaluate their tolerance. The primary endpoint was the ability to consume at least 600 mg of peanut protein, while secondary endpoints included tolerating at least 1,000 mg of milk, egg, or cashew protein without moderate to severe allergic symptoms. Results showed that 68% of patients in the Xolair treatment group could tolerate at least 600 mg of peanut protein, compared to just 5% in the placebo group (p<0.0001).
This marks the fourth major indication for Xolair, which was initially approved in 2003 for moderate-to-severe persistent asthma and later received approvals for chronic idiopathic urticaria in adults and adolescents, as well as for nasal polyps in adults aged 18 and older.- Flcube.com
