FDA Approves Xolair® (omalizumab) for Subcutaneous Use for People with Chronic Idiopathic Urticaria (CIU), a Form of Chronic Hives
March 21st, 2014
On March 21, 2014, the FDA approved Xolair for the treatment of chronic idiopathic urticaria (CIU), a form of chronic hives for people 12 years of age and older who remain symptomatic despite treatment with H1-antihistamine therapy.
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1 Asthma and Allergy Foundation of America (AAFA) website. “Chronic Urticaria (Hives).” http://www.aafa.org/display.cfm?id=9&sub=23&cont=328. Accessed March 11, 2014.
2 American Academy of Allergy Asthma & Immunology (AAAAI) website. “Skin Allergy Overview.” http://www.aaaai.org/conditions-and-treatments/allergies/skin-allergy.aspx. Accessed March 11, 2014.
3 Maurer M, Weller K, Bindslev-Jensen C, et al. Unmet clinical needs in chronic spontaneous urticaria. A GA2LEN task force report. Allergy 2011; 66: 317–330.
4 Census Bureau Projects U.S. Population of 317.3 Million on New Year's Day. United States Census Bureau. December 30, 2013. http://www.census.gov/newsroom/releases/archives/population/cb13-tps112.html. Accessed March 11, 2014.
5 Xolair® Full Prescribing Information. Genentech. March 21, 2014.
6 S. Saini. Chronic urticaria: Clinical manifestations, diagnosis, pathogenesis, and natural history. http://www.uptodate.com/contents/chronic-urticaria-clinical-manifestations-diagnosis-pathogenesis-and-natural-history. Accessed March 11, 2014.
“Chronic idiopathic urticaria can be difficult to manage because its causes are unknown, and other approved medicines aren’t effective enough for many patients. We are pleased to have Xolair as a new option for people with this serious skin condition.”
Sandra Horning, M.D., chief medical officer and head of Global Product Development