Omalizumab (Xolair) is FDA-approved for treatment of chronic urticaria (hives)

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

At any given time, the prevalence of chronic urticaria (CU) is up to 1% of the world's population, and up to two thirds of these patients have CIU (CSU). Approximately 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.

Many (up to 50%) of patients with CIU do not get adequate relief with antihistamines alone.

The efficacy and safety of omalizumab for CIU was demonstrated in 2 clinical studies — ASTERIA I and ASTERIA II.

In ASTERIA I, omalizumab 150 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.

Similar results were observed for the ASTERIA II study, published in the NEJM.

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 (ICS).

Chronic Urticaria Treatment - Illustrated

I updated the diagram about Chronic Urticaria Treatment Options with the addition of omalizumab and vitamin D, based on this study:

Chronic Urticaria Treatment Options (click to enlarge the image).

WAO TV interviews allergy experts about about urticaria

Tom Casale, the AAAAI executive vice president and author of one of the NEJM articles, was interviewed for the World Allergy Organization (WAO) TV this month and he correctly predicted omalizumab approval based on the current evidence:

Dr Casale: Efficacy Of Omalizumab In Patients With Chronic Urticaria - YouTube

Dr Tarbox: Choosing Wisely List and Chronic Urticaria - YouTube

WAO TV is for you - send us suggestions for interviews

I am the editor-in-chief of WAO TV. Feel free to send suggestions for articles and future interviews. Here is our work list which you can edit directly on Google Drive:

Watch the rest of the WAO TV videos here:


Novartis announces US FDA approval of Xolair® for chronic idiopathic urticaria (CIU)

Omalizumab for the treatment of chronic idiopathic or spontaneous urticaria. Maurer M1, Rosén K, Hsieh HJ, Saini S, Grattan C, Gimenéz-Arnau A, Agarwal S, Doyle R, Canvin J, Kaplan A, Casale T. N Engl J Med. 2013 Mar 7;368(10):924-35. doi: 10.1056/NEJMoa1215372. Epub 2013 Feb 24.

Beneficial role for supplemental vitamin D3 treatment in chronic urticaria: a randomized study. Andy Rorie et al. Annals of Allergy, Asthma & Immunology, 02/2014.

FDA OKs Omalizumab (Xolair) for Chronic Hives. Medscape, 2014

Image source: Urticaria, Wikipedia, public domain.

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