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.

•   References

  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.