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FDA approves Xolair® (omalizumab) for people with Chronic Idiopathic Urticaria (CIU), a form of chronic hives

Novartis has announced that the US Food and Drug Administration (FDA) approved Xolair® (omalizumab) for the treatment of chronic idiopathic urticaria (CIU), a form of chronic hives. The new use is for patients 12 years of age and older who remain symptomatic despite treatment with H1-antihistamine therapy. Xolair is not used to treat other forms of urticaria (hives) and is not for use in children less than 12 years of age. Xolair is jointly developed by Genentech and Novartis Pharma AG and is co-promoted by Novartis Pharmaceuticals Corporation with Genentech in the United States.

CIU is characterized by hives that spontaneously occur without an identifiable cause and reoccur for six weeks or more. CIU symptoms include red, swollen, itchy and sometimes painful hives on the skin that can be burdensome and last for many months and even years. Nearly 50% of these patients remain symptomatic despite treatment with approved doses of H1-antihistamines, the only previously FDA-approved therapy for CIU. In the US, it is estimated that approximately 1.5 million people suffer from CIU. Women are twice as likely as men to experience CIU and most people develop symptoms between the ages of 20 and 40 years.

“For CIU patients, it can take months or even years to get the right diagnosis and some relief,” said AndrĂ© Wyss, President, Novartis Pharmaceuticals Corporation, and President, Novartis Corporation. “Novartis is proud to have collaborated with clinicians to bring forward a new treatment option for those who suffer from this serious skin condition. This is part of our quest to deliver innovative medicines that address unmet need.”

“CIU can be a frustrating condition for patients,” said 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.”

Xolair is the first medicine approved by the FDA for CIU since H1-antihistamines.

The clinical profile of Xolair for the treatment of CIU was evaluated in two studies called ASTERIA I and ASTERIA II. In these studies, 641 patients 12 to 75 years old received subcutaneous injections of Xolair at 75 mg, 150 mg, 300 mg, or placebo. Xolair or placebo was given every four weeks for 24 weeks (ASTERIA I) and 12 weeks (ASTERIA II). In addition, patients continued to receive the H1-antihistamine treatment they had been taking for CIU before starting treatment with Xolair.

Efficacy and Safety Findings

The efficacy of Xolair in patients 12 years and older who remained symptomatic despite approved doses of H1-antihistamine treatment was assessed in two Phase III studies, ASTERIA I and II. The studies used scales known as the average (mean) weekly Itch Severity Score (ISS) and the weekly hive count score, where potential scores ranged from 0 to 21 for both scales. Xolair 300 mg and 150 mg met the primary endpoint across these studies, which showed Xolair significantly improved the Itch Severity Score. In addition, Xolair 300 mg and 150 mg significantly decreased the weekly hive count score. In many cases, patients reported no itch or hives at week 12.

In ASTERIA I, Xolair 150 mg improved ISS from the starting measurement by a reduction of 6.7 (47%) and Xolair 300 mg improved ISS from the starting measurement by a reduction of 9.4 (66%) at Week 12, compared to a reduction of 3.6 (25%) score improvement for patients who received placebo. Also, a larger proportion of patients (36%) treated with Xolair 300 mg reported no itch and no hives at Week 12, compared to patients treated with Xolair 150 mg (15%), and patients in the placebo group (9%). Similar results were observed for the ASTERIA II study. The 75-mg dose did not demonstrate consistent evidence of efficacy and is not approved for use.

The most common side effects in patients treated with Xolair were nausea, headaches, swelling of the inside of the nose, throat or sinuses, cough, joint pain, and upper respiratory tract infection.

Xolair in Allergic Asthma

Xolair was originally approved in the US in 2003 for people 12 years and older with moderate to severe persistent allergic asthma caused by year-round allergens in the air and not controlled by asthma medicines called inhaled steroids. Xolair should not be used to treat other allergic conditions. Xolair is not a rescue medicine and should not be used to treat sudden asthma attacks. Xolair should not be used in children under 12 years of age.


Novartis Pharmaceuticals Corporation