Fasenra

benralizumab

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This is a summary of the European public assessment report (EPAR) for Fasenra. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Fasenra.

For practical information about using Fasenra, patients should read the package leaflet or contact their doctor or pharmacist.

What is Fasenra and what is it used for?

Fasenra is an asthma medicine used to treat adults with a particular type of asthma called eosinophilic asthma.

It is used as an additional treatment in adults with severe asthma that is not adequately controlled by a combination of high-dose inhaled corticosteroids plus medicines called long-acting beta-agonists.

Fasenra contains the active substance benralizumab.

How is Fasenra used?

Fasenra is available as a solution for injection in pre-filled syringes. The recommended dose is 30 mg injected under the skin of the upper arm, thighs or belly every 4 weeks for the first 3 doses, and every 8 weeks afterwards. Fasenra should be given for as long as the patient benefits from it, and doctors should re-assess at least once a year whether treatment should be continued.

The medicine can only be obtained with a prescription and should be prescribed by doctors with experience in the diagnosis and treatment of severe asthma.

For further information, see the package leaflet.

How does Fasenra work?

In eosinophilic asthma, symptoms are associated with having too many of a type of white blood cell called eosinophils in the blood and in phlegm in the lungs. The active substance in Fasenra, benralizumab, is a monoclonal antibody (a type of protein) designed to attach to receptors (targets) called interleukin-5 receptors on the surface of eosinophils. By attaching to interleukin-5 receptors, Fasenra activates the immune system (the body’s natural defences) to kill the eosinophils in the blood and lungs. This helps to reduce inflammation, resulting in a reduction in asthma attacks and improvement of symptoms.

What benefits of Fasenra have been shown in studies?

Fasenra was shown to reduce the number of exacerbations (flare-ups) of asthma during treatment in 2 main studies involving a total of 2,511 patients with eosinophilic asthma that was not adequately controlled by a combination of high-dose inhaled corticosteroids and long-acting beta-agonists. Among patients with the highest number of blood eosinophils before treatment, the number of severe flare-ups per year was 0.66 in patients treated with Fasenra (given every 4 weeks for the first 3 doses and every 8 weeks afterwards), compared with 1.14 in patients given placebo (a dummy treatment).

A third study involving 220 patients showed that more patients given Fasenra had their condition improved to the extent that they could reduce their dose of corticosteroids by an average of 75% compared with 25% of those given placebo.

What are the risks associated with Fasenra?

The most common side effects with Fasenra (which may affect up to 1 in 10 people) include headache and pharyngitis (sore throat). For the full list of side effects and restrictions with Fasenra, see the package leaflet.

Why is Fasenra approved?

Fasenra has been shown to be more effective than placebo at reducing the number of asthma flare-ups and the need for corticosteroid treatment. The medicine is well tolerated with few side effects. The European Medicines Agency therefore decided that Fasenra’s benefits are greater than its risks and recommended that it be approved for use in the EU.

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

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Fasenra have been included in the summary of product characteristics and the package leaflet.

Other information about Fasenra

The European Commission granted a marketing authorisation valid throughout the European Union for Fasenra on 8 January 2018

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

Name Language First published Last updated
Fasenra : EPAR - Summary for the public BG = bălgarski 2018-03-08  
Fasenra : EPAR - Summary for the public ES = español 2018-03-08  
Fasenra : EPAR - Summary for the public CS = čeština 2018-03-08  
Fasenra : EPAR - Summary for the public DA = dansk 2018-03-08  
Fasenra : EPAR - Summary for the public DE = Deutsch 2018-03-08  
Fasenra : EPAR - Summary for the public ET = eesti keel 2018-03-08  
Fasenra : EPAR - Summary for the public EL = elliniká 2018-03-08  
Fasenra : EPAR - Summary for the public EN = English 2018-03-08  
Fasenra : EPAR - Summary for the public FR = français 2018-03-08  
Fasenra : EPAR - Summary for the public IT = italiano 2018-03-08  
Fasenra : EPAR - Summary for the public LV = latviešu valoda 2018-03-08  
Fasenra : EPAR - Summary for the public LT = lietuvių kalba 2018-03-08  
Fasenra : EPAR - Summary for the public HU = magyar 2018-03-08  
Fasenra : EPAR - Summary for the public MT = Malti 2018-03-08  
Fasenra : EPAR - Summary for the public NL = Nederlands 2018-03-08  
Fasenra : EPAR - Summary for the public PL = polski 2018-03-08  
Fasenra : EPAR - Summary for the public PT = português 2018-03-08  
Fasenra : EPAR - Summary for the public RO = română 2018-03-08  
Fasenra : EPAR - Summary for the public SK = slovenčina 2018-03-08  
Fasenra : EPAR - Summary for the public SL = slovenščina 2018-03-08  
Fasenra : EPAR - Summary for the public FI = suomi 2018-03-08  
Fasenra : EPAR - Summary for the public SV = svenska 2018-03-08  
Fasenra : EPAR - Summary for the public HR = Hrvatski 2018-03-08  

This EPAR was last updated on 18/05/2018 .

Authorisation details

Product details

Product details for Fasenra
NameFasenra
Agency product numberEMEA/H/C/004433
Active substance

benralizumab

International non-proprietary name (INN) or common name

benralizumab

Therapeutic area Asthma
Anatomical therapeutic chemical (ATC) code R03DX10
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Publication details

Publication details for Fasenra
Marketing-authorisation holder

AstraZeneca AB

Revision1
Date of issue of marketing authorisation valid throughout the European Union08/01/2018

Contact address:

AstraZeneca AB
SE-151 85 
Sodertalje 
Sweden

Product information

Product information

28/02/2018  Fasenra -EMEA/H/C/004433 -IAIN/0001

Name Language First published Last updated
Fasenra : EPAR - Product Information HR = Hrvatski 2018-03-08 2018-05-18
Fasenra : EPAR - Product Information HR = Hrvatski 2018-03-08 2018-05-18
Fasenra : EPAR - Product Information HR = Hrvatski 2018-03-08 2018-05-18
Fasenra : EPAR - Product Information HR = Hrvatski 2018-03-08 2018-05-18
Fasenra : EPAR - Product Information HR = Hrvatski 2018-03-08 2018-05-18
Fasenra : EPAR - Product Information HR = Hrvatski 2018-03-08 2018-05-18
Fasenra : EPAR - Product Information HR = Hrvatski 2018-03-08 2018-05-18
Fasenra : EPAR - Product Information HR = Hrvatski 2018-03-08 2018-05-18
Fasenra : EPAR - Product Information HR = Hrvatski 2018-03-08 2018-05-18
Fasenra : EPAR - Product Information HR = Hrvatski 2018-03-08 2018-05-18
Fasenra : EPAR - Product Information HR = Hrvatski 2018-03-08 2018-05-18
Fasenra : EPAR - Product Information HR = Hrvatski 2018-03-08 2018-05-18
Fasenra : EPAR - Product Information HR = Hrvatski 2018-03-08 2018-05-18
Fasenra : EPAR - Product Information HR = Hrvatski 2018-03-08 2018-05-18
Fasenra : EPAR - Product Information HR = Hrvatski 2018-03-08 2018-05-18
Fasenra : EPAR - Product Information HR = Hrvatski 2018-03-08 2018-05-18
Fasenra : EPAR - Product Information HR = Hrvatski 2018-03-08 2018-05-18
Fasenra : EPAR - Product Information HR = Hrvatski 2018-03-08 2018-05-18
Fasenra : EPAR - Product Information HR = Hrvatski 2018-03-08 2018-05-18
Fasenra : EPAR - Product Information HR = Hrvatski 2018-03-08 2018-05-18
Fasenra : EPAR - Product Information HR = Hrvatski 2018-03-08 2018-05-18
Fasenra : EPAR - Product Information HR = Hrvatski 2018-03-08 2018-05-18
Fasenra : EPAR - Product Information HR = Hrvatski 2018-03-08 2018-05-18
Fasenra : EPAR - Product Information HR = Hrvatski 2018-03-08 2018-05-18
Fasenra : EPAR - Product Information HR = Hrvatski 2018-03-08 2018-05-18

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
Fasenra : EPAR - All Authorised presentations HR = Hrvatski 2018-03-08  
Fasenra : EPAR - All Authorised presentations HR = Hrvatski 2018-03-08  
Fasenra : EPAR - All Authorised presentations HR = Hrvatski 2018-03-08  
Fasenra : EPAR - All Authorised presentations HR = Hrvatski 2018-03-08  
Fasenra : EPAR - All Authorised presentations HR = Hrvatski 2018-03-08  
Fasenra : EPAR - All Authorised presentations HR = Hrvatski 2018-03-08  
Fasenra : EPAR - All Authorised presentations HR = Hrvatski 2018-03-08  
Fasenra : EPAR - All Authorised presentations HR = Hrvatski 2018-03-08  
Fasenra : EPAR - All Authorised presentations HR = Hrvatski 2018-03-08  
Fasenra : EPAR - All Authorised presentations HR = Hrvatski 2018-03-08  
Fasenra : EPAR - All Authorised presentations HR = Hrvatski 2018-03-08  
Fasenra : EPAR - All Authorised presentations HR = Hrvatski 2018-03-08  
Fasenra : EPAR - All Authorised presentations HR = Hrvatski 2018-03-08  
Fasenra : EPAR - All Authorised presentations HR = Hrvatski 2018-03-08  
Fasenra : EPAR - All Authorised presentations HR = Hrvatski 2018-03-08  
Fasenra : EPAR - All Authorised presentations HR = Hrvatski 2018-03-08  
Fasenra : EPAR - All Authorised presentations HR = Hrvatski 2018-03-08  
Fasenra : EPAR - All Authorised presentations HR = Hrvatski 2018-03-08  
Fasenra : EPAR - All Authorised presentations HR = Hrvatski 2018-03-08  
Fasenra : EPAR - All Authorised presentations HR = Hrvatski 2018-03-08  
Fasenra : EPAR - All Authorised presentations HR = Hrvatski 2018-03-08  
Fasenra : EPAR - All Authorised presentations HR = Hrvatski 2018-03-08  
Fasenra : EPAR - All Authorised presentations HR = Hrvatski 2018-03-08  
Fasenra : EPAR - All Authorised presentations HR = Hrvatski 2018-03-08  
Fasenra : EPAR - All Authorised presentations HR = Hrvatski 2018-03-08  

Pharmacotherapeutic group

Drugs for obstructive airway diseases

Therapeutic indication

Fasenra is indicated as an add on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long acting β agonists.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Fasenra : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2018-05-18  

Initial marketing-authorisation documents

Name Language First published Last updated
Fasenra : EPAR - Public assessment report HR = Hrvatski 2018-03-08  
CHMP summary of positive opinion for Fasenra HR = Hrvatski 2017-11-10  

Authorised

This medicine is approved for use in the European Union