Xolair's approval for chronic hives (2014)
The U.S. Food and Drug Administration approved omalizumab, sold as Xolair by Roche and Novartis, for chronic spontaneous urticaria in patients who did not respond to antihistamines. It was the first biologic approved for the condition.
Xolair became the standard add-on biologic for CSU, generating billions in annual sales.
It established anti-IgE therapy as the mechanism of choice for the disease and set the efficacy benchmark CUE-221 now compares against.
CUE-221's trial used Xolair as an active comparator, and its durability advantage at 12 weeks off treatment is aimed at the incumbent's main weakness: patients rebound when dosing stops.
