Cinqaero

reslizumab

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This is a summary of the European public assessment report (EPAR) for Cinqaero. 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 Cinqaero.

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

What is Cinqaero and what is it used for?

Cinqaero is an asthma medicine that is 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 properly controlled by a combination of high-dose corticosteroids taken by inhalation plus another medicine used for the prevention of asthma. The medicine contains the active substance reslizumab.

How is Cinqaero used?

Cinqaero can only be obtained with a prescription and should be prescribed by doctors with experience in the treatment of eosinophilic asthma. It is available as a concentrate for making a solution for infusion (drip) into a vein. The recommended dose is 3 mg for each kg of bodyweight. The infusion should be given once every four weeks, for as long as the patient is considered to benefit, and doctors should re-assess at least once a year whether treatment should be continued. For further information, see the package leaflet.

How does Cinqaero 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 Cinqaero, reslizumab, is a monoclonal antibody designed to attach to a substance called interleukin-5, which stimulates the growth and activity of eosinophils. By attaching to interleukin-5 and blocking its activity, Cinquaero reduces the number of 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 Cinqaero have been shown in studies?

The benefits of Cinqaero have been shown in two main studies involving 953 patients with eosinophilic asthma that was not well controlled by inhaled corticosteroids and other asthma medication used for the prevention of the disease. Cinqaero was compared with placebo (a dummy infusion), both given every 4 weeks for a year. The main measure of effectiveness was based on the number of flare-ups (exacerbations) of asthma during treatment. Flare-ups were seen in 32% of patients (151 out of 477) given Cinqaero compared with 50% (237 out of 476) of those given placebo. Additionally there was evidence of an improvement in lung function and asthma symptoms, and a decrease in number of eosinophils in the blood in patients given Cinqaero. Supportive data suggested that the benefit was maintained for up to two years.

What are the risks associated with Cinqaero?

The most common side effect with Cinqaero (which may affect about 2 people in 100) is an increase in levels of the enzyme creatine phosphokinase in the blood (a measure of possible damage to muscles). Anaphylactic (severe allergic) reactions may affect less than 1 person in 100.

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

Why is Cinqaero approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Cinqaero’s benefits are greater than its risks and recommended that it be approved for use in the EU. The reduction in flare-ups and improvement in lung function seen with Cinqaero were considered clinically relevant, particularly for patients who cannot be adequately controlled with high doses of inhaled corticosteroids and another medicine used for the prevention of asthma. Overall the medicine was well tolerated, and appropriate measures to monitor and manage risks have been put in place.

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

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

Other information about Cinqaero

The European Commission granted a marketing authorisation valid throughout the European Union for Cinqaero on 16 August 2016.

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

Name Language First published Last updated
Cinqaero : EPAR - Summary for the public BG = bălgarski 2016-09-02  
Cinqaero : EPAR - Summary for the public ES = español 2016-09-02  
Cinqaero : EPAR - Summary for the public CS = čeština 2016-09-02  
Cinqaero : EPAR - Summary for the public DA = dansk 2016-09-02  
Cinqaero : EPAR - Summary for the public DE = Deutsch 2016-09-02  
Cinqaero : EPAR - Summary for the public ET = eesti keel 2016-09-02  
Cinqaero : EPAR - Summary for the public EL = elliniká 2016-09-02  
Cinqaero : EPAR - Summary for the public EN = English 2016-09-02  
Cinqaero : EPAR - Summary for the public FR = français 2016-09-02  
Cinqaero : EPAR - Summary for the public IT = italiano 2016-09-02  
Cinqaero : EPAR - Summary for the public LV = latviešu valoda 2016-09-02  
Cinqaero : EPAR - Summary for the public LT = lietuvių kalba 2016-09-02  
Cinqaero : EPAR - Summary for the public HU = magyar 2016-09-02  
Cinqaero : EPAR - Summary for the public MT = Malti 2016-09-02  
Cinqaero : EPAR - Summary for the public NL = Nederlands 2016-09-02  
Cinqaero : EPAR - Summary for the public PL = polski 2016-09-02  
Cinqaero : EPAR - Summary for the public PT = português 2016-09-02  
Cinqaero : EPAR - Summary for the public RO = română 2016-09-02  
Cinqaero : EPAR - Summary for the public SK = slovenčina 2016-09-02  
Cinqaero : EPAR - Summary for the public SL = slovenščina 2016-09-02  
Cinqaero : EPAR - Summary for the public FI = suomi 2016-09-02  
Cinqaero : EPAR - Summary for the public SV = svenska 2016-09-02  
Cinqaero : EPAR - Summary for the public HR = Hrvatski 2016-09-02  

This EPAR was last updated on 02/09/2016 .

Authorisation details

Product details

Product details for Cinqaero
NameCinqaero
Agency product numberEMEA/H/C/003912
Active substance

reslizumab

International non-proprietary name (INN) or common name

reslizumab

Therapeutic area Asthma
Anatomical therapeutic chemical (ATC) code R03DX08
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 Cinqaero
Marketing-authorisation holder

Teva Pharmaceuticals Limited

Revision0
Date of issue of marketing authorisation valid throughout the European Union16/08/2016

Contact address:

Teva Pharmaceuticals Limited
Riding Point Whistler Drive 
West Yorkshire 
Catleford WF10 5HX 
United Kingdom

Product information

Product information

16/08/2016  Cinqaero -EMEA/H/C/003912 --

Name Language First published Last updated
Cinqaero : EPAR - Product Information HR = Hrvatski 2016-09-02  
Cinqaero : EPAR - Product Information HR = Hrvatski 2016-09-02  
Cinqaero : EPAR - Product Information HR = Hrvatski 2016-09-02  
Cinqaero : EPAR - Product Information HR = Hrvatski 2016-09-02  
Cinqaero : EPAR - Product Information HR = Hrvatski 2016-09-02  
Cinqaero : EPAR - Product Information HR = Hrvatski 2016-09-02  
Cinqaero : EPAR - Product Information HR = Hrvatski 2016-09-02  
Cinqaero : EPAR - Product Information HR = Hrvatski 2016-09-02  
Cinqaero : EPAR - Product Information HR = Hrvatski 2016-09-02  
Cinqaero : EPAR - Product Information HR = Hrvatski 2016-09-02  
Cinqaero : EPAR - Product Information HR = Hrvatski 2016-09-02  
Cinqaero : EPAR - Product Information HR = Hrvatski 2016-09-02  
Cinqaero : EPAR - Product Information HR = Hrvatski 2016-09-02  
Cinqaero : EPAR - Product Information HR = Hrvatski 2016-09-02  
Cinqaero : EPAR - Product Information HR = Hrvatski 2016-09-02  
Cinqaero : EPAR - Product Information HR = Hrvatski 2016-09-02  
Cinqaero : EPAR - Product Information HR = Hrvatski 2016-09-02  
Cinqaero : EPAR - Product Information HR = Hrvatski 2016-09-02  
Cinqaero : EPAR - Product Information HR = Hrvatski 2016-09-02  
Cinqaero : EPAR - Product Information HR = Hrvatski 2016-09-02  
Cinqaero : EPAR - Product Information HR = Hrvatski 2016-09-02  
Cinqaero : EPAR - Product Information HR = Hrvatski 2016-09-02  
Cinqaero : EPAR - Product Information HR = Hrvatski 2016-09-02  
Cinqaero : EPAR - Product Information HR = Hrvatski 2016-09-02  
Cinqaero : EPAR - Product Information HR = Hrvatski 2016-09-02  

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
Cinqaero : EPAR - All Authorised presentations HR = Hrvatski 2016-09-02  
Cinqaero : EPAR - All Authorised presentations HR = Hrvatski 2016-09-02  
Cinqaero : EPAR - All Authorised presentations HR = Hrvatski 2016-09-02  
Cinqaero : EPAR - All Authorised presentations HR = Hrvatski 2016-09-02  
Cinqaero : EPAR - All Authorised presentations HR = Hrvatski 2016-09-02  
Cinqaero : EPAR - All Authorised presentations HR = Hrvatski 2016-09-02  
Cinqaero : EPAR - All Authorised presentations HR = Hrvatski 2016-09-02  
Cinqaero : EPAR - All Authorised presentations HR = Hrvatski 2016-09-02  
Cinqaero : EPAR - All Authorised presentations HR = Hrvatski 2016-09-02  
Cinqaero : EPAR - All Authorised presentations HR = Hrvatski 2016-09-02  
Cinqaero : EPAR - All Authorised presentations HR = Hrvatski 2016-09-02  
Cinqaero : EPAR - All Authorised presentations HR = Hrvatski 2016-09-02  
Cinqaero : EPAR - All Authorised presentations HR = Hrvatski 2016-09-02  
Cinqaero : EPAR - All Authorised presentations HR = Hrvatski 2016-09-02  
Cinqaero : EPAR - All Authorised presentations HR = Hrvatski 2016-09-02  
Cinqaero : EPAR - All Authorised presentations HR = Hrvatski 2016-09-02  
Cinqaero : EPAR - All Authorised presentations HR = Hrvatski 2016-09-02  
Cinqaero : EPAR - All Authorised presentations HR = Hrvatski 2016-09-02  
Cinqaero : EPAR - All Authorised presentations HR = Hrvatski 2016-09-02  
Cinqaero : EPAR - All Authorised presentations HR = Hrvatski 2016-09-02  
Cinqaero : EPAR - All Authorised presentations HR = Hrvatski 2016-09-02  
Cinqaero : EPAR - All Authorised presentations HR = Hrvatski 2016-09-02  
Cinqaero : EPAR - All Authorised presentations HR = Hrvatski 2016-09-02  
Cinqaero : EPAR - All Authorised presentations HR = Hrvatski 2016-09-02  
Cinqaero : EPAR - All Authorised presentations HR = Hrvatski 2016-09-02  

Pharmacotherapeutic group

Other systemic drugs for obstructive airway diseases, other systemic drugs for obstructive airway diseases

Therapeutic indication

Cinqaero is indicated as add-on therapy in adult patients with severe eosinophilic asthma inadequately controlled despite high dose inhaled corticosteroids plus another medicinal product for maintenance treatment (see section 5.1).

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Cinqaero : EPAR - Public assessment report HR = Hrvatski 2016-09-02  
CHMP summary of positive opinion for Cinqaero HR = Hrvatski 2016-06-24  

Authorised

This medicine is approved for use in the European Union