Xolair Receiving FDA Safety Review

Jamie Sheller

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Data from an ongoing study, called EXCELS, indicates an increased number of heart attacks and strokes among patients using Xolair. After seeing that data, the FDA announced its safety review of Xolair. Genentech makes Xolair, and the drug is co-marketed by Novartis. Xolair's FDA-approved use is for the treatment of moderate to severe persistent asthma in patients ages 12 and older. After Xolair was approved in 2003, part of the post-approval process was the ongoing study, which was started in 2004. The EXCELS study compares 5,000 patients using Xolair with 2,500 patients not using the drug. EXCELS is an observational study, rather than a randomized clincal trial-the type of study that more clearly establishes cause-and-effect. Therefore, the FDA is working to get more information. At this time, the FDA has not recommended label changes for Xolair, and is not advising patients to stop using it.