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Author: Novartis Europharm Ltd.


Long information

What is it?

Xolair is a medicine that contains the active substance omalizumab. It is available in two forms: as a vial containing a powder and solvent that are made up into a solution for injection; and as a prefilled syringe containing a solution for injection. Each vial and syringe contains 75 or 150 mg of omalizumab.

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Table of Contents
What is it used for?
How is it used?
How does it work?
How has it been studied?
What benefits has it shown during the studies?
What is the risk associated?
Why has it been approved?

What is it used for?

Xolair is used to improve the control of severe persistent asthma that is caused by an allergy. It is used as an add-on to existing asthma treatment in patients aged six years or over.

All patients receiving Xolair must meet the following criteria:

they must have had a positive skin test result for an allergy caused by an allergen a stimulus that causes an allergy in the air, such as house dust mites, pollen or mould

they must have frequent symptoms during the day or waking up during the night

they must have had many severe exacerbations of asthma where asthma gets worse, requiring rescue treatment with other medicines despite treatment with high doses of inhaled corticosteroids plus a long-acting inhaled beta2 agonist.

Patients aged 12 years or over must also have reduced lung function (less than 80% of normal).

For patients of all ages, Xolair treatment should only be considered when the asthma is caused by an antibody called immunoglobulin E (IgE).

The medicine can only be obtained with a prescription.

How is it used?

Xolair treatment should be started by a doctor who has experience in the treatment of severe persistent asthma.

Before giving Xolair, the doctor must measure the level of IgE in the patient?s blood. Patients with low IgE levels are less likely to benefit from the medicine. Xolair is given by a healthcare professional as an injection under the skin of the shoulder or the thigh every two or four weeks. The dose of Xolair and how often it is given depend on the level of IgE in the blood and body weight. The usual dose range is between 75 and 600 mg in one to four injections, and the maximum recommended dose is 600 mg every two weeks.

Xolair is intended for long-term use. It usually takes 12 to 16 weeks for Xolair to show a benefit. See the summary of product characteristics (also part of the EPAR) for further information.

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How does it work?

The active substance in Xolair, omalizumab, is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) in the body. Omalizumab has been designed to attach to human IgE, which is produced in large quantities in patients with allergies and triggers an allergic reaction in response to an allergen. By attaching to IgE, omalizumab ?mops up? the free IgE circulating in the blood. This means that when the body encounters an allergen, there is less IgE available to trigger an allergic reaction. This helps to reduce the symptoms of allergy, such as asthma attacks.

How has it been studied?

Xolair has been studied in over 2,000 patients aged 12 years or over with allergic asthma in five main studies, including one study involving 482 patients with severe allergic asthma that was not controlled by conventional treatments. It has also been studied in 627 children aged between six and 12 years.

In all of the studies, Xolair was compared with placebo (a dummy treatment), when they were added to the patients? existing treatment. The main measures of effectiveness were the number of exacerbations, the number of patients who had an exacerbation, quality of life (assessed using standard questionnaires), and the amount of inhaled corticosteroid that the patients needed to take to treat their asthma.

What benefits has it shown during the studies?

In patients aged 12 years or over, Xolair reduced the number of exacerbations by around half. Over the first 28 or 52 weeks of treatment in the first three studies, there were around 0.5 exacerbations per year in the Xolair group and around one per year in the placebo group. In addition, fewer of the patients receiving Xolair had exacerbations than those receiving placebo. They also reported a greater improvement in quality of life and used less fluticasone (a corticosteroid). The effects of Xolair were greater in patients with severe asthma.

In the study of patients with severe allergic asthma, there was no difference in the number of asthma exacerbations between Xolair and placebo, but Xolair led to a similar reduction in the number of exacerbations as in previous studies.

In the study in children aged between six and 12 years, the number of exacerbations was lower in those receiving Xolair. Among the 235 children who were being treated with high doses of inhaled corticosteroids plus a long-acting inhaled beta2 agonist before the start of the study, there was an average of 0.4 exacerbations over the first 24 weeks of treatment in those receiving Xolair, compared with 0.6 in those receiving placebo.

What is the risk associated?

In patients aged 12 years and over, the most common side effects with Xolair (seen in between 1 and 10 patients in 100) are headache and injection site reactions, including swelling, redness, pain and itching. In children aged between six and 12 years, the most common side effects (seen in more than 1 patient in 10) are headache and pyrexia (fever). For the full list of all side effects reported with Xolair, see the package leaflet.

Xolair should not be used in people who may be hypersensitive (allergic) to omalizumab or any of the other ingredients.

Why has it been approved?

The CHMP concluded that, overall, there was a pattern of results in the studies of Xolair that show that it is effective in treating severe allergic asthma. Therefore, the Committee decided that Xolair?s benefits are greater than its risks and recommended that it be given marketing authorisation.

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