Xolair

omalizumab

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This is a summary of the European public assessment report (EPAR) for Xolair. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Xolair.

What is Xolair?

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.

What is Xolair 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. Xolair treatment should only be considered when the asthma is caused by an antibody called immunoglobulin E (IgE). 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).

Xolair is also used to treat chronic (long-term) spontaneous urticaria (itchy rash). It is used as an add-on to existing treatment in patients aged 12 years or over who do not respond to treatment with antihistamines.

The medicine can only be obtained with a prescription.

How is Xolair used?

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

For the treatment of asthma, Xolair is given by a healthcare professional as an injection under the skin of the shoulder or the thigh every two or four weeks. Before giving Xolair to patients with asthma, 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. 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.

In the treatment of asthma, Xolair is intended for long-term use. It usually takes 12 to 16 weeks for Xolair to show a benefit.

For the treatment of chronic spontaneous urticaria, Xolair is given by a healthcare professional by injection under the skin of the shoulder or the thigh, in a dose of 300 mg every four weeks. The doctor will periodically re-assess the need to continue treatment with Xolair.

How does Xolair 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. Although the role of IgE in chronic spontaneous urticaria is less clear, reducing its availability with omalizumab has been shown to improve the symptoms of this condition.

How has Xolair 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.

Xolair has also been investigated in 3 main studies involving a total of 978 patients with chronic spontaneous urticaria who did not respond to antihistamine-based treatment. In all of the studies, Xolair was compared with placebo, when they were added to the patients’ existing treatment. The main measure of effectiveness was the change in itching severity after 12 weeks of treatment, as measured on a scale ranging from 0 (no itch) to 21 (maximum itch severity).

What benefit has Xolair shown during the studies?

In the studies in patients with allergic asthma 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 with allergic asthma 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.

In the studies in patients with chronic spontaneous urticaria, following 12 weeks of treatment, Xolair 300 mg improved the symptoms of itching by 4.5 to 5.8 points more than placebo. The effects were maintained after 6 months of treatment.

What is the risk associated with Xolair?

In patients with allergic asthma 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).

In patients with chronic spontaneous urticaria, the most common side effects with Xolair (seen in between 1 and 10 patients in 100) are sinusitis (inflammation of the sinuses), headache, arthralgia (joint pain), injection site reactions and upper respiratory tract infection (colds).

For the full list of all side effects and restrictions with Xolair, see the package leaflet.

Why has Xolair been approved?

The CHMP decided that Xolair’s benefits are greater than its risks and recommended that it be given marketing authorisation. The Committee concluded that, overall, there was a pattern of results in the studies of Xolair in asthma that show that the medicine is effective in treating severe allergic asthma. The CHMP also concluded that Xolair (300 mg) was shown to significantly improve the symptoms of chronic spontaneous urticaria when used as add-on to the patients’ existing treatment, but noted that study data on long-term use beyond 6 months are limited.

What measures are being taken to ensure the safe and effective use of Xolair?

A risk management plan has been developed to ensure that Xolair is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Xolair, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about Xolair

The European Commission granted a marketing authorisation valid throughout the European Union for Xolair on 25 October 2005.

For more information about treatment with Xolair, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Xolair : EPAR - Summary for the public BG = bălgarski 2009-08-19 2014-04-03
Xolair : EPAR - Summary for the public ES = español 2009-08-19 2014-04-03
Xolair : EPAR - Summary for the public CS = čeština 2009-08-19 2014-04-03
Xolair : EPAR - Summary for the public DA = dansk 2009-08-19 2014-04-03
Xolair : EPAR - Summary for the public DE = Deutsch 2009-08-19 2014-04-03
Xolair : EPAR - Summary for the public ET = eesti keel 2009-08-19 2014-04-03
Xolair : EPAR - Summary for the public EL = elliniká 2009-08-19 2014-04-03
Xolair : EPAR - Summary for the public EN = English 2009-08-19 2014-04-03
Xolair : EPAR - Summary for the public FR = français 2009-08-19 2014-04-03
Xolair : EPAR - Summary for the public IT = italiano 2009-08-19 2014-04-03
Xolair : EPAR - Summary for the public LV = latviešu valoda 2009-08-19 2014-04-03
Xolair : EPAR - Summary for the public LT = lietuvių kalba 2009-08-19 2014-04-03
Xolair : EPAR - Summary for the public HU = magyar 2009-08-19 2014-04-03
Xolair : EPAR - Summary for the public MT = Malti 2009-08-19 2014-04-03
Xolair : EPAR - Summary for the public NL = Nederlands 2009-08-19 2014-04-03
Xolair : EPAR - Summary for the public PL = polski 2009-08-19 2014-04-03
Xolair : EPAR - Summary for the public PT = português 2009-08-19 2014-04-03
Xolair : EPAR - Summary for the public RO = română 2009-08-19 2014-04-03
Xolair : EPAR - Summary for the public SK = slovenčina 2009-08-19 2014-04-03
Xolair : EPAR - Summary for the public SL = slovenščina 2009-08-19 2014-04-03
Xolair : EPAR - Summary for the public FI = suomi 2009-08-19 2014-04-03
Xolair : EPAR - Summary for the public SV = svenska 2009-08-19 2014-04-03
Xolair : EPAR - Summary for the public HR = Hrvatski 2009-08-19 2014-04-03

This EPAR was last updated on 10/10/2016 .

Authorisation details

Product details

Product details for Xolair
NameXolair
Agency product numberEMEA/H/C/000606
Active substance

omalizumab

International non-proprietary name (INN) or common name

omalizumab

Therapeutic area UrticariaAsthma
Anatomical therapeutic chemical (ATC) code R03DX05

Publication details

Publication details for Xolair
Marketing-authorisation holder

Novartis Europharm Ltd

Revision24
Date of issue of marketing authorisation valid throughout the European Union25/10/2005

Contact address:

Novartis Europharm Ltd
Frimley Business Park
Camberley
GU16 7SR
United Kingdom

Product information

Product information

09/09/2016  Xolair -EMEA/H/C/000606 -PSUSA/2214/201512

Name Language First published Last updated
Xolair : EPAR - Product Information HR = Hrvatski 2009-08-13 2016-10-10
Xolair : EPAR - Product Information HR = Hrvatski 2009-08-13 2016-10-10
Xolair : EPAR - Product Information HR = Hrvatski 2009-08-13 2016-10-10
Xolair : EPAR - Product Information HR = Hrvatski 2009-08-13 2016-10-10
Xolair : EPAR - Product Information HR = Hrvatski 2009-08-13 2016-10-10
Xolair : EPAR - Product Information HR = Hrvatski 2009-08-13 2016-10-10
Xolair : EPAR - Product Information HR = Hrvatski 2009-08-13 2016-10-10
Xolair : EPAR - Product Information HR = Hrvatski 2009-08-13 2016-10-10
Xolair : EPAR - Product Information HR = Hrvatski 2009-08-13 2016-10-10
Xolair : EPAR - Product Information HR = Hrvatski 2009-08-13 2016-10-10
Xolair : EPAR - Product Information HR = Hrvatski 2009-08-13 2016-10-10
Xolair : EPAR - Product Information HR = Hrvatski 2009-08-13 2016-10-10
Xolair : EPAR - Product Information HR = Hrvatski 2009-08-13 2016-10-10
Xolair : EPAR - Product Information HR = Hrvatski 2009-08-13 2016-10-10
Xolair : EPAR - Product Information HR = Hrvatski 2009-08-13 2016-10-10
Xolair : EPAR - Product Information HR = Hrvatski 2009-08-13 2016-10-10
Xolair : EPAR - Product Information HR = Hrvatski 2009-08-13 2016-10-10
Xolair : EPAR - Product Information HR = Hrvatski 2009-08-13 2016-10-10
Xolair : EPAR - Product Information HR = Hrvatski 2009-08-13 2016-10-10
Xolair : EPAR - Product Information HR = Hrvatski 2009-08-13 2016-10-10
Xolair : EPAR - Product Information HR = Hrvatski 2009-08-13 2016-10-10
Xolair : EPAR - Product Information HR = Hrvatski 2009-08-13 2016-10-10
Xolair : EPAR - Product Information HR = Hrvatski 2009-08-13 2016-10-10
Xolair : EPAR - Product Information HR = Hrvatski 2009-08-13 2016-10-10
Xolair : EPAR - Product Information HR = Hrvatski 2009-08-13 2016-10-10

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Xolair : EPAR - All Authorised presentations HR = Hrvatski 2009-08-13  
Xolair : EPAR - All Authorised presentations HR = Hrvatski 2009-08-13  
Xolair : EPAR - All Authorised presentations HR = Hrvatski 2009-08-13  
Xolair : EPAR - All Authorised presentations HR = Hrvatski 2009-08-13  
Xolair : EPAR - All Authorised presentations HR = Hrvatski 2009-08-13  
Xolair : EPAR - All Authorised presentations HR = Hrvatski 2009-08-13  
Xolair : EPAR - All Authorised presentations HR = Hrvatski 2009-08-13  
Xolair : EPAR - All Authorised presentations HR = Hrvatski 2009-08-13  
Xolair : EPAR - All Authorised presentations HR = Hrvatski 2009-08-13  
Xolair : EPAR - All Authorised presentations HR = Hrvatski 2009-08-13  
Xolair : EPAR - All Authorised presentations HR = Hrvatski 2009-08-13  
Xolair : EPAR - All Authorised presentations HR = Hrvatski 2009-08-13  
Xolair : EPAR - All Authorised presentations HR = Hrvatski 2009-08-13  
Xolair : EPAR - All Authorised presentations HR = Hrvatski 2009-08-13  
Xolair : EPAR - All Authorised presentations HR = Hrvatski 2009-08-13  
Xolair : EPAR - All Authorised presentations HR = Hrvatski 2009-08-13  
Xolair : EPAR - All Authorised presentations HR = Hrvatski 2009-08-13  
Xolair : EPAR - All Authorised presentations HR = Hrvatski 2009-08-13  
Xolair : EPAR - All Authorised presentations HR = Hrvatski 2009-08-13  
Xolair : EPAR - All Authorised presentations HR = Hrvatski 2009-08-13  
Xolair : EPAR - All Authorised presentations HR = Hrvatski 2009-08-13  
Xolair : EPAR - All Authorised presentations HR = Hrvatski 2009-08-13  
Xolair : EPAR - All Authorised presentations HR = Hrvatski 2009-08-13  

Pharmacotherapeutic group

Drugs for obstructive airway diseases

Therapeutic indication

Allergic asthma

Xolair is indicated in adults, adolescents and children (6 to <12 years of age). Xolair treatment should only be considered for patients with convincing IgE (immunoglobulin E) mediated asthma (see section 4.2).

Adults and adolescents (12 years of age and older) Xolair is indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and who have reduced lung function (FEV1 <80%) as well as frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist.

Children (6 to <12 years of age) Xolair is indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist. Xolair treatment should only be considered for patients with convincing IgE (immunoglobulin E) mediated asthma (see section 4.2).

Chronic spontaneous urticaria (CSU)

Xolair is indicated as add-on therapy for the treatment of chronic spontaneous urticaria in adult and adolescent (12 years and above) patients with inadequate response to H1 antihistamine treatment.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Xolair : EPAR - Procedural steps taken before authorisation HR = Hrvatski 2005-11-25  
Xolair : EPAR - Scientific Discussion HR = Hrvatski 2005-11-25  

Authorised

This medicine is approved for use in the European Union