Genentech, a member of the Roche Group (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 therapy. Until now, H1-antihistamines have been the only approved therapy for CIU, with about 50 percent of patients having an inadequate response.
CIU 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 40.
"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."
Xolair is the first biologic medicine and first medicine approved by the FDA for CIU since non-sedating H1-antihistamines. Xolair is approved for people 12 years and older with CIU who remain symptomatic despite treatment with H1-antihistamine therapy. Xolair is not used to treat other forms of urticaria (hives) and is not for use in children less than 12 years of age. It is jointly developed by Genentech and Novartis Pharma AG and is co-promoted in the U.S. with Novartis Pharmaceuticals Corporation.
"CIU can be a frustrating condition for patients," said Mike Tringale, senior vice president at the Asthma and Allergy Foundation of America (AAFA). "This new use for Xolair gives hope to appropriate patients who can go for months or even years without getting satisfactory itch and hive reduction."
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.
Efficacy and Safety Findings
The efficacy of Xolair in patients 12 years and older who remained symptomatic despite taking H1-antihistamines was assessed using a scale known as the average (mean) weekly Itch Severity Score (ISS) at Week 12. The weekly ISS has potential scores ranging from 0 to 21. In ASTERIA I, Xolair 150 mg improved ISS from the starting measurement by 47 percent (-6.7) and Xolair 300 mg improved ISS from the starting measurement by 66 percent (-9.4) at Week 12, compared to a 25 percent (-3.6) score improvement for patients who received placebo. Also, a larger proportion of patients (36 percent) treated with Xolair 300 mg reported no itch and no hives at Week 12, compared to patients treated with Xolair 150 mg (15 percent), and patients in the placebo group (9 percent). Similar results were observed for the ASTERIA II study.
The most common side effects in patients treated with Xolair were nausea, headaches, swelling of the inside of the nose, throat or sinuses, cough, joint pain, and upper respiratory tract infection.