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Xolair (Omalizumab) - Summary

 
 



XOLAIR SUMMARY

Xolair (Omalizumab) is a recombinant DNA-derived humanized IgG1(kappa) monoclonal antibody that selectively binds to human immunoglobulin E (IgE).

Xolair (Omalizumab) is indicated for adults and adolescents (12 years of age and above) with moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids. Xolair has been shown to decrease the incidence of asthma exacerbations in these patients. Safety and efficacy have not been established in other allergic conditions.


See all Xolair indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Xolair (Omalizumab)

FDA approves Xolair® (omalizumab) for people with Chronic Idiopathic Urticaria (CIU), a form of chronic hives
Source: Allergy News From Medical News Today [2014.03.25]
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.

FDA Approves Xolair for Chronic Hives
Source: MedPage Today Allergy & Immunology [2014.03.21]
(MedPage Today) -- The FDA has approved omalizumab (Xolair) for treatment of chronic idiopathic urticaria, drugmaker Genentech announced.

New indication for Xolair approved by the European Commission for treatment in chronic spontaneous urticaria patients
Source: Allergy News From Medical News Today [2014.03.10]
Novartis has announced that the European Commission (EC) has approved the use of Xolair® as an add-on therapy for the treatment of chronic spontaneous urticaria (CSU) in adult and adolescent (12...

Xolair® improves rate of severe asthma exacerbations
Source: Doctors Lounge - Chest Diseases
Xolair reduced the rate of hospital emergency visits by 44% in patients with inadequately controlled asthma.

Oral immunotherapy with antibody-based medication could be used to treat multiple food allergies
Source: Allergy News From Medical News Today [2014.02.27]
By combining standard desensitization of up to five food allergies with antibody-based medication omalizumab, it may be possible to treat multiple food allergies in a shorter timeframe.

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Published Studies Related to Xolair (Omalizumab)

Omalizumab and the risk of malignancy: results from a pooled analysis. [2012]
pooled data from clinical trials of omalizumab-treated patients... CONCLUSIONS: In this pooled analysis no association was observed between

A randomized, placebo-controlled, dose-ranging study of single-dose omalizumab in patients with H1-antihistamine-refractory chronic idiopathic urticaria. [2011.09]
BACKGROUND: Proof-of-concept studies with omalizumab in patients with chronic idiopathic urticaria (CIU) have shown significant decreases in mean urticaria activity scores (UASs). OBJECTIVE: We sought to evaluate the efficacy and safety of omalizumab in patients with CIU who remain symptomatic despite concomitant H(1)-antihistamine therapy... CONCLUSION: This study demonstrated that a fixed dose of 300 or 600 mg of omalizumab provides rapid and effective treatment of CIU in patients who are symptomatic despite treatment with H(1)-antihistamines. Copyright (c) 2011 American Academy of Allergy, Asthma & Immunology. Published by Mosby, Inc. All rights reserved.

Efficacy and safety of omalizumab in patients with chronic urticaria who exhibit IgE against thyroperoxidase. [2011.07]
BACKGROUND: A subgroup of patients with chronic spontaneous urticaria (CU) exhibits IgE antibodies directed against autoantigens, such as thyroperoxidase (TPO). We conducted this study to investigate whether such patients with CU with IgE against TPO benefit from treatment with omalizumab, a humanized anti-IgE mAb licensed for the treatment of severe persistent allergic (IgE-mediated) asthma. OBJECTIVES: We sought to assess the efficacy of omalizumab treatment in patients with CU with IgE autoantibodies against TPO... CONCLUSIONS: The results of this study indicate that omalizumab is an effective treatment option for patients with CU with IgE autoantibodies against TPO who are refractory to conventional treatment. Copyright (c) 2011 American Academy of Allergy, Asthma & Immunology. Published by Mosby, Inc. All rights reserved.

Omalizumab in severe allergic asthma inadequately controlled with standard therapy: a randomized trial. [2011.05.03]
BACKGROUND: Inhaled corticosteroids (ICS) and long-acting beta(2)-agonists (LABAs) are recommended in patients with asthma that is not well-controlled; however, many patients continue to have inadequately controlled asthma despite this therapy. OBJECTIVE: To evaluate the efficacy and safety of omalizumab in patients with inadequately controlled severe asthma who are receiving high-dose ICS and LABAs, with or without additional controller therapy... CONCLUSION: In this study, omalizumab provided additional clinical benefit for patients with severe allergic asthma that is inadequately controlled with high-dose ICS and LABA therapy. Primary Funding Source: Genentech and Novartis Pharmaceuticals.

Persistency of response to omalizumab therapy in severe allergic (IgE-mediated) asthma. [2011.05]
BACKGROUND: The physician's global evaluation of treatment effectiveness (GETE) at 16 weeks has been shown to be the most effective assessment of response to omalizumab (XOLAIR(R)). This randomized, open-label, parallel-group study evaluated the persistency of treatment responder classification in patients receiving omalizumab added to optimized asthma therapy (OAT)... CONCLUSION: Response to omalizumab, as assessed by a physician's GETE at 16 weeks, is an effective predictor of continuing persistent response to omalizumab for the majority of patients. (c) 2011 John Wiley & Sons A/S.

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Clinical Trials Related to Xolair (Omalizumab)

Study to Evaluate the Effect of Xolair(Omalizumab) on Improving the Tolerability of Specific Immunotherapy in Patients With at Least Moderate Persistent Allergic Asthma Inadequately Controlled With Inhaled Corticosteroids [Completed]
In patients with at least moderate persistent allergic asthma controlled with inhaled steroids, omalizumab (administered per US product label), when compared to placebo, will provide the participants with significantly improved tolerability of specific allergen immunotherapy (allergy shots) administered per a cluster schedule(rapid build up method).

The Effect of Xolair (Omalizumab) on Allergy Blood Cells [Recruiting]
We are studying Xolair (omalizumab) to see it's effect on allergic blood cells. The blood tests will be done in a test tube to see if they react differently before and after treatment. The blood cells will be mixed with to whatever the person is allergic.

Effect of Xolair on Airway Hyperresponsiveness [Recruiting]
The purpose of this study is to determine if Xolair can reduce the abnormal increase in limitation to airflow in patients with asthma in a relatively short time period. Another purpose is to determine if Xolair will decrease the amount of inflammation in the lungs of an asthmatic patient in the same time period.

Effect of Ozone on Airway Inflammation in Allergic Asthmatics Treated With Omalizumab [Terminated]
Ozone can cause acute airway inflammation in both asthmatics and normal volunteers. However, in asthmatics ozone can cause episodes of worsening of asthma. We want to learn if chronic allergic response, known as "IgE-induced airway inflammation" is what causes the increased inflammation in response to ozone. To do this we will examine the response to ozone in a group of asthmatics treated with omalizumab, a medicine available and approved for use in people with asthma, or a placebo control. The placebo for this study is inert physiologic saline ("salt water") which contains no omalizumab. Both the omalizumab and the placebo will be administered as an injection under the skin. Omalizumab, also called Xolair, is a humanized monoclonal antibody, which means that it originally was produced in mice, then genetically engineered to look more like human than mouse antibody. Omalizumab inactivates IgE, a protein our own immune systems make as part of allergic reactions. The purpose of this study is to test the hypothesis that omalizumab, by blocking this aspect of allergic reactions, will decrease the number of inflammatory cells in the airway after ozone challenge. We also hypothesize that omalizumab will decrease the effects of ozone on changes in lung function, mucociliary clearance (a measure of how quickly mucus clears form the airway) and airway reactivity. Airway reactivity is a measure of how sensitive the airways are to a medication used to diagnose asthma, called methacholine. We will examine these as additional information we can learn during the course of the study. This is a blinded study, meaning that neither you nor the researchers know if you get the active drug or placebo, but that information can be obtained if needed. The placebo is an injection of inert physiological saline ("salt water") which contains no omalizumab.

Non-invasive Ways to Evaluate Lung Disease After Treatment With Xolair [Recruiting]
The purpose of this study is to study the effects of Xolair using non-invasive techniques from the expired gas of patients with moderate to severe allergic asthma.

more trials >>

Reports of Suspected Xolair (Omalizumab) Side Effects

Asthma (543)Dyspnoea (439)Cough (369)Nasopharyngitis (333)Fatigue (306)Wheezing (250)Malaise (230)Pneumonia (186)Blood Pressure Increased (178)Headache (169)more >>


Page last updated: 2014-03-25

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