FDA Approves Xolair for Chronic Idiopathic Urticaria
The FDA has approved Xolair (omalizumab) for the treatment of chronic idiopathic urticaria (CIU), a form of chronic hives. The new use is for patients 12 years of age and older 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. Xolair is jointly developed by Genentech and Novartis Pharma AG and is co-promoted by Novartis Pharmaceuticals Corporation with Genentech in the United States. CIU is characterized by hives that spontaneously occur without an identifiable cause and reoccur for six weeks or more. CIU symptoms include red, swollen, itchy and sometimes painful hives on the skin that can be burdensome and last for many months and even years. Nearly 50% of these patients remain symptomatic despite treatment with approved doses of H1-antihistamines, the only previously FDA-approved therapy for CIU. In the US, it is estimated that approximately 1.5 million people suffer from CIU. Women are twice as likely as men to experience CIU and most people develop symptoms between the ages of 20 and 40 years.
"For CIU patients, it can take months or even years to get the right diagnosis and some relief," said Andre Wyss, President, Novartis Pharmaceuticals Corporation, and President, Novartis Corporation.
"Novartis is proud to have collaborated with clinicians to bring forward a new treatment option for those who suffer from this serious skin condition. This is part of our quest to deliver innovative medicines that address unmet need." "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." Xolair is the first medicine approved by the FDA for CIU since H1-antihistamines.