Novartis’ Xolair has been recommended in global guidelines for treating chronic spontaneous urticaria in patients unresponsive to antihistamines.
Xolair (omalizumab) is the only licensed treatment option for CSU, a type of chronic urticaria (UC) causing itchy, persistent hives and painful swelling, when antihistamines are not effective.
In clinical trials, patients treated with Xolair for 12 weeks experienced significant improvements in quality of life by 78 percent (versus placebo 44 percent) as measured by the Dermatology Life Quality Index (DLQI), the firm noted.
The guidelines, which aim to achieve symptom control for patients, recommend the drug as the only treatment qualified with very good efficacy and very good safety in this setting.
"This guideline is encouraging news for CSU patients who have difficult to control symptoms," said Shreeram Aradhye chief medical officer and global head hedical affairs, Novartis Pharmaceuticals.
"The recommendation reinforces the important role of Xolair to provide effective symptom control in CSU when antihistamines prove inadequate. Xolair is the only biologic shown to be effective in CSU."