FDA Approves Genentech’s Xolair (omalizumab) for Allergic Asthma in Children
South San Francisco, CA -- July 7, 2016 -- 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 (omalizumab) to treat moderate to severe persistent asthma in children six to 11 years of age who have had a positive skin test or in vitro reactivity to an airborne allergen and have symptoms that are inadequately controlled with inhaled corticosteroids4. Xolair is already approved to treat people 12 years and older with allergic asthma.
"Despite our best efforts to control symptoms with inhaled corticosteroids and other medicines, allergic asthma remains a serious problem for many children," said Sandra Horning, M.D., chief medical officer and head of Global Product Development. "With this approval, we’re pleased to see a proven treatment option is now available for appropriate patients six and older."
Asthma is one of the most common long-term diseases in children1. It affects about 6.3 million people under 18 or one in 12 children in the U.S2. An estimated 24 million people in the U.S. have asthma. Of this patient population, approximately 60 percent have allergic asthma5 . The American Academy of Pediatrics estimates that between 70 and 80 percent of school-aged children with asthma also have allergies, which are among the most common triggers for asthma6.
"Uncontrolled allergic asthma can significantly affect the lives of children," said Cary Sennett, M.D., PhD, president and chief executive officer of the Asthma and Allergy Foundation of America (AAFA). "This approval helps to address an important unmet need for children older than six and their parents or caregivers."
Xolair was first approved in 2003 to treat adults and children 12 years of age and older with moderate to severe persistent allergic asthma not controlled by inhaled steroids. Since its U.S. approval, more than 200,000 patients older than 12 with allergic asthma have been treated with the medicine3. Xolair is not indicated for the treatment of other allergic conditions, acute bronchospasm (serious and sudden breathing problems) or status asthmaticus (acute, severe, prolonged asthma attack that can be life-threatening).
The latest approval is supported by multi-center, randomized, double-blind, placebo-controlled Phase III studies that assessed the efficacy and safety of Xolair in children from six to 11 years old with moderate to severe persistent uncontrolled allergic asthma. The primary study was a 52-week trial, with the primary endpoint measured at 24 weeks4. Supportive safety and efficacy data come from a 28-week study4. Additional safety data come from a five-year non-randomized observational post-marketing study to evaluate the long-term safety of Xolair in patients 12 years and older7.
Efficacy and Safety Findings
The 52-week study evaluated the safety and efficacy of Xolair as an add-on therapy in children from six to 11 years old with moderate to severe allergic asthma who were inadequately controlled despite the use of inhaled corticosteroids with or without the use of other controller asthma medications. During the first 24 weeks of treatment, steroid doses remained constant from baseline. This was followed by a 28-week period during which inhaled corticosteroid adjustment was allowed. The primary efficacy variable in this study was the rate of asthma exacerbations during the 24-week, fixed steroid treatment phase. An asthma exacerbation was defined as a worsening of asthma symptoms as judged clinically by the investigator, requiring doubling of the baseline inhaled corticosteroid dose for at least three days and/or treatment with rescue systemic corticosteroids for at least three days4.
At 24 weeks, the Xolair treatment group had a statistically significantly lower rate of asthma exacerbations compared to the placebo treatment group (0.45 vs. 0.64, respectively), representing a 31 percent relative rate reduction (rate ratio 0.69, 95 percent CI (0.53, 0.90) p=0.007)4. During the entire 52-week treatment period, the difference in asthma exacerbation rates between the Xolair and placebo treatment groups (0.78 vs. 1.36, respectively) represented a 43 percent relative rate reduction (rate ratio 0.57, 95 percent CI (0.45, 0.72) p<0.001)4.
In clinical studies with pediatric patients six to 11 years old, the most common side effects (≥3 percent in Xolair-treated patients and more frequent than placebo) were common cold symptoms (nasopharyngitis), headache, fever (pyrexia), upper abdominal pain, sore throat (pharyngitis streptococcal), ear discomfort (otitis media), intestinal infection causing abdominal pain, nausea and vomiting (viral gastroenteritis), insect bites (arthropod bites) and nose bleeding (epistaxis)4.
In the U.S., Genentech, Inc. and Novartis Pharmaceuticals Corporation work together to develop and co-promote Xolair.
Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. Novartis Pharmaceuticals Corporation researches, develops, manufactures and markets innovative medicines aimed at improving patients’ lives.
About Allergic Asthma
Asthma is a chronic condition with inflammation and narrowing of the airways, as well as tightening of the muscles around the airways.
The symptoms of asthma and allergic asthma are the same—it's the triggers that are different. What makes allergic asthma a unique type of asthma is the cause of its symptoms: exposure to year-round allergens in the air, such as pet dander and dust mites. If you have allergic asthma, allergens like these can bring on your allergic asthma symptoms and attacks.
When an allergen enters your body, your immune system identifies it as something harmful; Your immune system responds by releasing a substance called immunoglobulin E, or IgE; IgE plays a key role in the development of allergic asthma symptoms. It binds to allergens, which causes the release of chemicals that can lead to swelling (inflammation) in and around the lungs. This can trigger an allergic asthma attack.
People with allergic asthma may have higher levels of IgE because of the way their immune system reacts to allergens. For some, blocking IgE, which Xolair is designed to do, has been shown to be a helpful part of their allergic asthma treatment plan. If you think you may have allergic asthma, ask your doctor about how much IgE is in your body.
Xolair® for subcutaneous use is an injectable prescription medicine used to treat:
- moderate to severe persistent asthma in patients six years of age or older whose asthma symptoms are not controlled by asthma medicines called inhaled corticosteroids. A skin or blood test is performed to see if a patient has allergies to year-round allergens.
- chronic idiopathic urticaria (CIU; chronic hives without a known cause) in patients 12 years of age and older 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, acute bronchospasm or status asthmaticus.
About Xolair Access Solutions
Patients experiencing financial hardship may be eligible to receive coverage and reimbursement support for Xolair. Patient assistance and informational resources are available through Xolair Access Solutions (http://www.xolair.com/allergic-asthma/xolair-access-solutions.html).
Founded 40 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 http://www.gene.com.
2 U.S. Centers for Disease Control and Prevention. National Current Asthma Prevalence. http://www.cdc.gov/asthma/most_recent_data.htm. Accessed June 21, 2016.
3 Data on file. Genentech, Inc, South San Francisco, CA.
4 Xolair® Full Prescribing Information. Genentech. July 7, 2016.
5 Arbes S, Gergen P, Vaughn B, et al. Asthma cases attributable to atopy: Results from the Third National Health and Nutrition Examination Survey. J Allergy Clin Immunol 2007;120:1139-45.
6 American Academy of Pediatrics. Healthy Children.org. Guide to Your Child’s Allergies and Asthma. https://www.healthychildren.org/English/health-issues/conditions/allergies-asthma/Pages/Allergies.aspx. Accessed June 30, 2016.
7 Long A, Rahmaroui A, Rothman K, et al. Incidence of malignancy in patients with moderate-to-severe asthma treated with or without omalizumab. J Allergy Clin Immunol. 2014;134:560-7.
Posted: July 2016
- FDA Approves Xolair (omalizumab) Prefilled Syringe for Self-Injection Across All Indications - April 12, 2021
- Genentech Announces FDA Approval of Xolair (omalizumab) for Adults with Nasal Polyps - December 1, 2020
- FDA Approves Genentech's Xolair (omalizumab) Prefilled Syringe Formulation - September 28, 2018
- FDA Approves Xolair (omalizumab) for Chronic Idiopathic Urticaria - March 21, 2014
- FDA Approves Xolair (omalizumab) for Moderate-to-Severe Asthma - June 20, 2003
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.