FDA Approves Xolair(R) (omalizumab) for People with Chronic Idiopathic Urticaria (CIU), a Form of Chronic Hives

  Xolair is the First Biologic Medicine Approved for CIU, a Burdensome Skin Condition  that Can Cause Hives and Severe Itch and May Last Many Years.   Nearly 50 Percent of Patients Have Inadequate Response to H1-antihistamines, Previously the Only Approved Therapy for CIU3.  Approximately 1.5 Million People in U.S. have CIU.

Genentech Web





Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) approved Xolair(R) (omalizumab) for the treatment of chronic idiopathic urticaria (CIU), a form of chronic hives. The new use is for people 12 years of age and older who remain symptomatic despite treatment with H(1) -antihistamine therapy(5) . Until now, H(1) -antihistamines have been the only approved therapy for CIU, with about 50 percent of patients having an inadequate response(3) .

CIU is diagnosed when hives occur without an identifiable cause, spontaneously present, and reoccur for more than six weeks(1,3) . CIU can have burdensome symptoms including swelling, severe itch, pain, and discomfort that may last for many months and even years(1,2) . Approximately 1.5 million people in the U.S. develop CIU at some stage in their life(3,4) . Women are twice as likely as men to experience CIU and most develop symptoms between the ages of 20 and 40(3,6) .

“Chronic idiopathic urticaria can be difficult to manage because its causes are unknown, and other approved medicines aren’t effective enough for many patients,” said 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 the first biologic medicine and first medicine approved by the FDA for CIU since non-sedating H(1) -antihistamines. Xolair is approved for people 12 years and older with CIU who remain symptomatic despite treatment with H(1) -antihistamine therapy(5) . Xolair is not used to treat other forms of urticaria (hives) and is not for use in children less than 12 years of age. It is jointly developed by Genentech and Novartis Pharma AG and is co-promoted in the U.S. with Novartis Pharmaceuticals Corporation.

“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.”

The efficacy and safety profile of Xolair for the treatment of CIU was evaluated in two clinical studies called ASTERIA I and ASTERIA II(5) . In these studies, patients 12 to 75 years old received doses of Xolair at 150 mg, 300 mg or placebo(5) . Xolair or placebo was given every four weeks for 24 weeks (ASTERIA I) and 12 weeks (ASTERIA II). In addition, patients continued to receive H(1) -antihistamine medicines they had been taking for CIU before starting treatment with Xolair(5) .

Efficacy and Safety Findings

The efficacy of Xolair in patients 12 years and older who remained symptomatic despite taking H(1) -antihistamines was assessed using a scale known as the average (mean) weekly Itch Severity Score (ISS) at Week 12. The weekly ISS has potential scores ranging from 0 to 21(5) . In ASTERIA I, Xolair 150 mg improved ISS from the starting measurement by 47 percent (-6.7) and Xolair 300 mg improved ISS from the starting measurement by 66 percent (-9.4) at Week 12, compared to a 25 percent (-3.6) score improvement for patients who received placebo(5) . Also, a larger proportion of patients (36 percent) treated with Xolair 300 mg reported no itch and no hives at Week 12, compared to patients treated with Xolair 150 mg (15 percent), and patients in the placebo group (9 percent)(5) . Similar results were observed for the ASTERIA II study(5) .

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(5) .

About Xolair

Xolair for subcutaneous use is an injectable prescription medicine used to treat adults and children 12 years of age and older 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.
  • chronic idiopathic urticaria (CIU; chronic hives without a known cause) who continue to have hives that are not controlled by H1-antihistamine treatment.

Xolair is not used to treat other allergic conditions, other forms of urticaria (hives), acute bronchospasm (serious and sudden breathing problems) or status asthmaticus (acute, severe, prolonged asthma attack that can be life threatening). Xolair is not for use in children less than 12 years of age.

Click here for Important Safety Information.


Please see full Prescribing Information, including Medication Guide for additional important safety information at www.xolair.com.

About Genentech Access Solutions

Genentech is committed to people having access to its medicines. Genentech Access Solutions is a team of more than 350 Genentech employees who help those who need its medicines. Knowledgeable and experienced specialists can help patients and medical practices navigate the access and reimbursement process and provide assistance to eligible patients in the U.S. who do not have insurance coverage or who cannot afford their out-of-pocket co-pay costs. For more information, please visit Genentech-Access.com.

About Genentech

Founded more than 35 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit www.gene.com.

About AAFA

The Asthma and Allergy Foundation of America (AAFA) is a not-for-profit organization founded in 1953. AAFA is the leading patient organization for people with asthma, allergies and related conditions, and provides practical information, community based services and support through a national network of chapters and support groups. AAFA develops health education, organizes state and national advocacy efforts and funds research to find better treatments and cures. Learn more about AAFA at www.aafa.org.


1 Asthma and Allergy Foundation of America (AAFA) website. “Chronic Urticaria (Hives).” http://www.aafa.org/display.cfm?id=9&sub=23&cont=328. Accessed March 11, 2014.

2 American Academy of Allergy Asthma & Immunology (AAAAI) website. “Skin Allergy Overview.” http://www.aaaai.org/conditions-and-treatments/allergies/skin-allergy.aspx. Accessed March 11, 2014.

3 Maurer M, Weller K, Bindslev-Jensen C, et al. Unmet clinical needs in chronic spontaneous urticaria. A GA2LEN task force report. Allergy 2011; 66: 317–330.

4 Census Bureau Projects U.S. Population of 317.3 Million on New Year’s Day. United States Census Bureau. December 30, 2013. http://www.census.gov/newsroom/releases/archives/population/cb13-tps112.html. Accessed March 11, 2014

5 Xolair(R) Full Prescribing Information. Genentech. March 21, 2014

6 S. Saini. Chronic urticaria: Clinical manifestations, diagnosis, pathogenesis, and natural history. http://www.uptodate.com/contents/chronic-urticaria-clinical-manifestations-diagnosis-pathogenesis-and-natural-history. Accessed March 11, 2014.

Media Contact:

Allison S. Neves, 650-467-6800

Investor Contacts:

Thomas Kudsk Larsen, 650-467-2016

Karl Mahler, 011 41 61 687 8503

Posted in AZBio News.