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FDA approves Xolair for chronic idiopathic urticaria
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The FDA approved omalizumab for the treatment of chronic idiopathic urticaria, a form of chronic hives, according to a press release. It is the first medication approved for the condition since H1-antihistamines.
Omalizumab (Xolair, Genentech/Novartis) was initially approved in the United States in 2003 for patients aged 12 years and older with moderate-to-severe persistent allergic asthma due to year-round allergens not otherwise controlled by inhaled corticosteroids.
The agent is indicated for patients aged 12 years and older who are symptomatic despite treatment with H1-antihistamine therapy, according to the release. The agent is not indicated for the use of other forms of urticaria, nor is it indicated for children aged younger than 12 years.
In two clinical trials, ASTERIA I and ASTERIA II, researchers found that patients reported no itch or hives at week 12 of therapy. The most common adverse events associated with omalizumab were nausea, headaches, swelling of the inside of the nose, throat or sinuses, cough, joint pain, and upper respiratory tract infection.
For more information:
ClinicalTrials.gov Identifier: NCT00866788.
Perspective
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Timothy J. Craig, DO, FAAAAI
It think it’s going to be a great step. There’s a small portion of patients with chronic urtcaria that don’t respond well to medications. When I was in a clinical trial with this, I was very impressed. I didn’t know who was on placebo or not, but I was still very impressed on patients’ response. I’m very excited to have another tool in the armamentarium for treating urticaria. In many studies, the research is minimal and not well controlled beyond antihistamine treatment arms; the drug we always wind up going to is cyclosporine, which can be expensive and potentially toxic. This will be a great addition.
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