The Food and Drug Administration has approved omalizumab (Xolair) for chronic idiopathic urticaria in people 12 years of age and older who remain symptomatic despite treatment with H1-antihistamine therapy.
Omalizumab was first approved in 2003 for moderate to severe asthma. In 2007, the FDA required the drug to be administered in a doctor’s office only, to monitor for potentially severe anaphylaxis; a boxed warning was added at that time.
According to the drug’s developer, Genentech, omalizumab is the first biologic and the first medicine approved for chronic idiopathic urticaria since nonsedating H1-antihistamines.
The approval was based on the results from two studies, ASTERIA I and ASTERIA II5, which were presented in November 2013 at the annual congress of the European Academy of Dermatology and Venereology.
According to Genentech, about 1.5 million Americans develop chronic idiopathic urticaria at some point, with women twice as likely as men to get the condition.
Chronic idiopathic urticaria "can be a frustrating condition for patients," said Mike Tringale, senior vice president at the Asthma and Allergy Foundation of America in a statement issued by Genentech. "This new use for Xolair gives hope to appropriate patients who can go for months or even years without getting satisfactory itch and hive reduction."
Omalizumab was jointly developed by Genentech and Novartis Pharma, and is copromoted in the United States with Novartis.
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