The Food and Drug Administration has approved Xolair (omalizumab), a medication jointly developed by Genentech and Novartis for the treatment of chronic idiopathic urticaria (CIU), a form of chronic hives.


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Xolair from Genentech, Novartis cleared by FDA

March 24th, 2014

SOUTH SAN FRANCISCO, Calif. – The Food and Drug Administration has approved Xolair (omalizumab), a medication jointly developed by Genentech and Novartis for the treatment of chronic idiopathic urticaria (CIU), a form of chronic hives.

Genentech said Friday that the product, an injectable prescription medicine, is the first biologic medicine approved by the FDA for CIU since non-sedating H1-antihistamines.

The new use is for people age 12 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 half of patients having an inadequate response, according to the company.

CIU is diagnosed when hives occur without an identifiable cause, spontaneously present, and reoccur for more than six weeks. CIU can have such symptoms as swelling, severe itch, pain and discomfort that may linger for many months and even years. Approximately 1.5 million people in the United States 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," stated 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 co-promoted in the United States with Novartis Pharmaceuticals Corp.

"CIU can be a frustrating condition for patients," stated 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."

Besides CIU, Xolair is also used to treat people with moderate to severe persistent allergic asthma who have had a skin or blood test that is positive for allergic asthma and whose asthma symptoms are not controlled by asthma medicines called inhaled corticosteroids.

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