What is Xolair?
Xolair is a medicine that contains the active substance omalizumab. It is available in two forms: a vial containing a powder and a solvent that form a solution for injection; a pre-filled syringe containing a solution for injection. Each vial and each syringe contain 75 or 150 mg of omalizumab.
What is Xolair used for?
Xolair is indicated to improve the control of severe persistent asthma caused by an allergy. It is used in adjunctive therapy for asthma in patients aged six years and over.
All patients treated with Xolair must meet the following criteria:
- have obtained a positive result in the skin test for an allergy caused by an allergen (a substance that causes an allergy) present in the air, such as domestic mites, pollen or mold,
- have frequent daytime symptoms or nocturnal awakenings,
- must have had repeated severe asthma exacerbations (acute asthma, requiring the use of rescue drugs along with other medicines) despite the intake of high doses of inhaled corticosteroids, plus a long beta2-agonist inhaled action.
Patients 12 years of age and older must also have reduced lung function (less than 80% compared to the norm).
For patients of all ages, treatment with Xolair should only be considered when asthma is caused by an antibody called immunoglobulin E (IgE).
The medicine can only be obtained with a prescription .
How is Xolair used?
Treatment with Xolair should be started by a doctor who has experience in the treatment of severe persistent asthma.
Before administering 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 should be given by a healthcare professional (a doctor or nurse) by subcutaneous injection (under the skin), shoulder or thigh, every two or four weeks. The dosage of Xolair and its frequency depend on the level of IgE in the blood and body weight. Generally the dose is between 75 and 375 mg in one to three injections; the maximum recommended dose is
375 mg every two weeks. Generally it takes 12 to 16 weeks for Xolair to present a benefit. For more information, please refer to the summary of product characteristics, also included with the EPAR.
How does Xolair work?
The active substance in Xolair, omalizumab, is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) designed to recognize and bind to a specific structure (the antigen) in the body. Omalizumab was designed to bind to human IgE, which is produced in large quantities in allergic patients and which trigger an allergic reaction in response to an allergen. By binding to IgE, omalizumab "absorbs" free IgE circulating in the blood. This means that when the body encounters an allergen, less IgE is available which can trigger an allergic reaction. This reduces the symptoms of allergy such as asthma attacks.
How has Xolair been studied?
Xolair has been studied in allergic asthmatic subjects, 12 years of age and over, in five main studies involving 2 299 patients, including a study carried out on 482 patients suffering from severe allergic asthma not controlled by traditional treatments. It has also been studied in 627 children between six and 12 years of age.
In all the studies, Xolair was compared with a placebo (a dummy treatment), used as an adjunctive therapy to the patient's ongoing treatment. The main indicators of effectiveness were the number of exacerbations, the number of patients with exacerbations of asthma, the quality of life of patients (assessed on the basis of standard questionnaires) and the amount of corticosteroid inhaled necessary for the patient to treat asthma .
What benefit has Xolair shown during the studies?
In patients 12 years of age and older, Xolair reduced the number of exacerbations by about half. In the first three studies, during the first 28 or 52 weeks of treatment, approximately 0.5 exacerbations per year were recorded in the Xolair group compared to one per year in the placebo group. Furthermore, fewer patients treated with Xolair experienced exacerbations than those treated with placebo. Among them a greater improvement in the quality of life and a lower use of fluticasone (a corticosteroid) was also detected. The effects of Xolair have been more effective in patients with severe asthma. In the study carried out on patients with severe allergic asthma, no difference was found in the number of exacerbations with Xolair or placebo, although Xolair caused a similar decrease in the number of exacerbations found in previous studies.
In the study of children between six and 12 years of age, the number of exacerbations was lower in those treated with Xolair. Among the 235 children treated before the start of the study with high doses of inhaled corticosteroids in addition to a long-acting beta2-agonist by inhalation, there were on average 0.4 exacerbations in the first 24 weeks of treatment with Xolair, compared to 0.6 for placebo-treated children.
What is the risk associated with Xolair?
The most common side effects seen with Xolair in patients 12 years of age and over (seen between 1 and 10 patients in 100) are headache and reactions at the injection site, including swelling, erythema (redness), pain and itching. In children between six and 12 years of age, the most common side effects (seen in over one in 10 patients) 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 other substances in the medicine.
Why has Xolair been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in general, a pattern of results is found in the studies performed with Xolair that demonstrates its effectiveness in treating severe allergic asthma. The Committee therefore decided that Xolair's benefits outweigh its risks as an adjunctive therapy to improve asthma control in patients over six years of age with persistent severe allergic asthma. The committee recommended that Xolair be given marketing authorization.
More information on Xolair
On 25 October 2005, the European Commission issued a marketing authorization valid for Xolair, valid throughout the European Union, to Novartis Europharm Limited.
The full EPAR for Xolair can be found here.
Last update of this summary: 07-2009.
