Novartis’ Xoliar recommended as add-on therapy for chronic spontaneous urticaria for patients unresponsive to antihistamines

Novartis’ Xolair has been recommended in new global chronic urticaria guideline, the company noted Tuesday, as add-on therapy for the treatment of chronic spontaneous urticaria (CSU), for patients who are not responding to antihistamines, and is the only licensed treatment option for this type of CU.

CU, including CSU, is a severe disease that causes itchy, persistent hives and painful swelling. As said by Novartis in its press release, the guideline recommends Xolair as the only treatment qualified with very good efficacy and very good safety in CSU.

Marcus Maurer, a Director of Research at the Department of Dermatology and Allergy, in Berlin, Germany said that the new guideline brings greater public awareness of the disease and treatment and that it provides clear directions for physicians on how to treat patients suffering from this undertreated, debilitating disease.

Shreeram Aradhye Chief Medical Officer and Global Head Medical Affairs, Novartis Pharmaceuticals, noted that the recommendation reinforces the important role of Xolair to provide effective symptom control in CSU when antihistamines prove inadequate. As he points out, “Xolair is the only biologic shown to be effective in CSU.”

According to Novartis’s press release, the new guideline aims to achieve complete symptom control of patients. Studies have shown that CSU, if not controlled, or only partially controlled, has a major impact on the quality of sleep and the social and working lives of patients, Novartis said. Furthermore, patients treated with Xolair for 12 weeks experienced significant improvements in quality of life by 78% (vs placebo 44%, p<0.0001) as measured by the Dermatology Life Quality Index (DLQI). In addition, Novartis puts, data show that almost 90% of CSU patients who responded well to initial Xolair treatment regained symptom control within 12 weeks of Xolair retreatment following a treatment interruption, based on Weekly Urticaria Activity Score (UAS7) criteria (UAS7<=6). Xolair is currently only licensed for CSU. Novartis added that Xolair is also approved for the treatment of moderate-to-severe or severe persistent allergic asthma.

About Xolair
Xolair is a targeted therapy that binds to immunoglobulin E (IgE). In allergic diseases and asthma, the binding of IgE by Xolair reduces symptoms by suppressing multiple cell activation mechanisms, including some that result in histamine release. Research is ongoing to better understand the mechanism of action of Xolair in CSU, which could lead to a deeper understanding of how the disease develops.