Roche 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 therapy. Until now, H1-antihistamines have been the only approved therapy for CIU, with about 50% of patients having an inadequate response.
“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, 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. CIU can have burdensome symptoms including swelling, severe itch, pain and discomfort that may last for many months and even years. Approximately 1.5 million people in the U.S. develop CIU at some stage in their life. 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 II. In these studies, patients 12 to 75 years old received doses of Xolair at 150 mg, 300 mg or placebo. 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 Xolair.
Date: March 24, 2014