FDA approves Xolair (omalizumab) for people with Chronic Idiopathic Urticaria, a form of chronic hives

• First biologic medicine approved for CIU, a burdensome skin condition that can cause hives and severe itch and may last many years^1,2
• Nearly 50 percent of patients have inadequate response to H1-antihistamines, previously the only approved therapy for CIU³

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) approved Xolair (omalizumab) for the treatment of chronic idiopathic urticaria (CIU), a form of chronic hives. The new use is for people 12 years of age and older who remain symptomatic despite treatment with H1-antihistamine therapy⁵. Until now, H1-antihistamines have been the only approved therapy for CIU, with about 50 percent of patients having an inadequate response³.

“Chronic idiopathic urticaria can be difficult to manage because its causes are unknown, and other approved medicines aren’t effective enough for many patients,” said Sandra Horning, M.D., Chief Medical Officer and Head of Global Product Development. “We are pleased to have Xolair as a new option for people with this serious skin condition.”

CIU, also known as chronic spontaneous urticaria (CSU), is diagnosed when hives occur without an identifiable cause, spontaneously present and reoccur for more than six weeks^1.2. CIU can have burdensome symptoms including swelling, severe itch, pain and discomfort that may last for many months and even years^3,4. Approximately 1.5 million people in the U.S. develop CIU at some stage in their life^3,4. Women are twice as likely as men to experience CIU and most develop symptoms between the ages of 20 and 40³.

Xolair is the first biologic medicine and first medicine approved by the FDA for CIU since non-sedating H1-antihistamines. The efficacy and safety profile of Xolair for the treatment of CIU was evaluated in two clinical studies called ASTERIA I and ASTERIA II⁵. In these studies, patients 12 to 75 years old received doses of Xolair at 150 mg, 300 mg or placebo⁵. Xolair or placebo was given every four weeks for 24 weeks (ASTERIA I) and 12 weeks (ASTERIA II). In addition, patients continued to receive H1-antihistamine medicines they had been taking for CIU before starting treatment with Xolair⁵.

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 February 12, 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 February 12, 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 February 12, 2014
5. Xolair® Full Prescribing Information. Genentech, Inc. (Date TBD)