FDA OKs Omalizumab (Xolair) for Chronic Hives

Megan Brooks


March 21, 2014

The US Food and Drug Administration (FDA) today approved omalizumab subcutaneous injection (Xolair, Genentech, Novartis) for treatment of chronic idiopathic urticaria (CIU) in people aged 12 years or older who continue to have symptoms despite treatment with antihistamines.

Omalizumab is the first biologic medicine and the first new class of medicine approved for CIU since the introduction of nonsedating H1-antihistamines more than a decade ago, Genentech said in a statement.

Patients with CIU regularly develop hives with no obvious cause. It's estimated that 1.5 million Americans suffer from CIU, with women twice as likely as men to experience CIU, and most develop symptoms between the ages of 20 and 40.

Until now, antihistamines have been the only approved treatment for CIU. However, nearly 50% of patients with this form of chronic hives fail to get adequate relief.

"CIU can be a frustrating condition for patients," Mike Tringale, senior vice president at the Asthma and Allergy Foundation of America, said in the statement. "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 of omalizumab for CIU was demonstrated in 2 clinical studies — ASTERIA I and ASTERIA II.

In ASTERIA I, omalizumab150 mg improved itch-severity score (ISS) by 47% and omalizumab 300 mg improved ISS by 66% at Week 12, compared with a 25% score improvement for patients who received placebo.

A larger proportion of patients (36%) treated with omalizumab 300 mg reported no itch and no hives at Week 12, compared with patients treated with the 150-mg dose (15%) and placebo-treated patients (9%).

Similar results were observed for the ASTERIA II study and were reported at the American Academy of Allergy Asthma & Immunology's 2013 annual meeting, were simultaneously published in the New England Journal of Medicine, and were reported by Medscape Medical News.

The most common side effects with omalizumab for CIU are nausea; headaches; swelling of the inside of the nose, throat, or sinuses; cough; joint pain; and upper respiratory tract infection.

Omalizumab is also indicated for 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 inhaled corticosteroids.


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