Genentech approved for Xolair

SOUTH SAN FRANCISCO, Calif. — Genentech announced that the Food and Drug Administration approved Xolair (omalizumab) for the treatment of chronic idiopathic urticaria, or CIU, which is a form of chronic hives.



CIU is diagnosed when hives occur without cause, spontaneously present and reoccur for more than six weeks, the company said. The symptoms include swelling, severe itch, pain and discomfort that may last for months and, in some cases, years. 



“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.”

The company noted that approximately 1.5 million people in the United States develop CIU at some point in their life. Women are twice as likely as men to experience CIU, with most developing symptoms between the ages of 20 and 40 years old.