FDA Approves New Indication for Roche, Novartis’ Xolair

The FDA has given a green light to Roche and Novartis to market Xolair to patients in the U.S. with chronic idiopathic urticaria (CIU) who are at least 12 years old and who have not responded to conventional H1-antihistamine treatment.

Approval of the new indication was based on the results of several Phase III studies of patients 12 to 75 years old who were dosed with either 150 mg or 300 mg of Xolair (omalizumab) or placebo, alongside their antihistamine treatments. In all studies, patients on Xolair showed statistically significant improvement in itch severity as compared to placebo, the drugmakers say.

Xolair is the first biologic medicine, and the first new treatment, approved for patients with the disease in the U.S. Until this point, says Novartis spokesman David Epstein, H1-antihistamines had been the only licensed treatment for CIU.

Xolair was originally approved in the U.S. to treat patients with severe persistent allergic asthma uncontrolled by inhaled steroids. Xolair has EU approval not only for CIU but also for severe and persistent allergic asthma in patients from six years of age all the way to adulthood.

Xolair was jointly developed by Novartis and Roche subsidiary Genentech. — Lena Freund

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