Nucala

mepolizumab

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

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

What is Nucala and what is it used for?

Nucala is an asthma medicine used to treat adults with a particular type of asthma called eosinophilic asthma. It is used with other medicines in patients whose asthma is severe and not well controlled with previous treatments.

Nucala contains the active substance mepolizumab.

How is Nucala used?

Nucala should be prescribed by a doctor experienced in identifying and treating severe eosinophilic asthma, and can only be obtained with a prescription. It is available as a powder to make up a solution for injection, and is injected by a healthcare professional under the skin of the upper arm, thigh or abdomen (belly) once every 4 weeks. The recommended dose is 100 mg. Nucala is intended for long-term treatment.

How does Nucala 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 Nucala, mepolizumab, is a type of protein called a monoclonal antibody, which attaches to a specific substance in the body. Mepolizumab attaches to a substance called interleukin-5 which encourages the production and survival of eosinophils. By attaching to interleukin-5, mepolizumab blocks its action and thereby reduces the numbers of eosinophils. This helps to reduce inflammation, resulting in a reduction in asthma attacks and improvement of symptoms.

What benefits of Nucala have been shown in studies?

The benefits of Nucala in severe eosinophilic asthma that is not well controlled by previous treatment have been shown in three main studies, in which it was compared with a placebo (dummy) injection. The first study involved 616 adults and adolescents given Nucala every 4 weeks for a year, in addition to their regular asthma medicines. The second study involved 576 adults and adolescents given Nucala every 4 weeks for 28 weeks. The main measure of effectiveness in these studies was the number of severe attacks (exacerbations) of asthma that occurred during treatment, which was reduced by about half in patients given Nucala.

The third study involved 135 patients with eosinophilic asthma severe enough to need regular treatment by mouth with corticosteroids (potent anti-inflammatory medicines such as prednisone and prednisolone), and the main measure of effectiveness was how much the corticosteroid dose could be reduced using Nucala for 24 weeks compared with placebo. Over half (37 of 69) of the patients given Nucala were able to reduce their daily corticosteroid dose by more than 50% to a dose of 5 mg or less, and 10 of them were able to stop corticosteroids altogether, compared with about a third of those given placebo (22 of 66, of whom 5 were able to stop corticosteroids).

What are the risks associated with Nucala?

The most common side effect with Nucala (which may affect more than 1 in 10 people) is headache; reactions at the site of injection and back pain are also common, affecting up to 1 patient in 10. For the full list of all side effects and restrictions with Nucala, see the package leaflet.

Why is Nucala approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Nucala’s benefits are greater than its risks and recommended that it be approved for use in the EU. The reduction in severe asthma attacks and consequent need for hospital treatment was considered important and outweighed the low risk of side effects, since the medicine’s safety profile raised no major concerns. In addition, a reduction in corticosteroid dose of 5 mg daily, although modest, was considered clinically relevant, given the complications of long-term corticosteroid treatment.

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

A risk management plan has been developed to ensure that Nucala 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 Nucala, including the appropriate precautions to be followed by healthcare professionals and patients.

Further information can be found in the summary of the risk management plan.

Other information about Nucala

The European Commission granted a marketing authorisation valid throughout the European Union for Nucala on 2 December 2015.

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

Name Language First published Last updated
Nucala : EPAR - Summary for the public BG = bălgarski 2015-12-03  
Nucala : EPAR - Summary for the public ES = español 2015-12-03  
Nucala : EPAR - Summary for the public CS = čeština 2015-12-03  
Nucala : EPAR - Summary for the public DA = dansk 2015-12-03  
Nucala : EPAR - Summary for the public DE = Deutsch 2015-12-03  
Nucala : EPAR - Summary for the public ET = eesti keel 2015-12-03  
Nucala : EPAR - Summary for the public EL = elliniká 2015-12-03  
Nucala : EPAR - Summary for the public EN = English 2015-12-03  
Nucala : EPAR - Summary for the public FR = français 2015-12-03  
Nucala : EPAR - Summary for the public IT = italiano 2015-12-03  
Nucala : EPAR - Summary for the public LV = latviešu valoda 2015-12-03  
Nucala : EPAR - Summary for the public LT = lietuvių kalba 2015-12-03  
Nucala : EPAR - Summary for the public HU = magyar 2015-12-03  
Nucala : EPAR - Summary for the public MT = Malti 2015-12-03  
Nucala : EPAR - Summary for the public NL = Nederlands 2015-12-03  
Nucala : EPAR - Summary for the public PL = polski 2015-12-03  
Nucala : EPAR - Summary for the public PT = português 2015-12-03  
Nucala : EPAR - Summary for the public RO = română 2015-12-03  
Nucala : EPAR - Summary for the public SK = slovenčina 2015-12-03  
Nucala : EPAR - Summary for the public SL = slovenščina 2015-12-03  
Nucala : EPAR - Summary for the public FI = suomi 2015-12-03  
Nucala : EPAR - Summary for the public SV = svenska 2015-12-03  
Nucala : EPAR - Summary for the public HR = Hrvatski 2015-12-03  
Name Language First published Last updated
Nucala : EPAR - Risk-management-plan summary (English only) 2015-12-03  

This EPAR was last updated on 15/04/2016 .

Authorisation details

Product details

Product details for Nucala
NameNucala
Agency product numberEMEA/H/C/003860
Active substance

mepolizumab

International non-proprietary name (INN) or common name

mepolizumab

Therapeutic area Asthma
Anatomical therapeutic chemical (ATC) code R03DX09
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 Nucala
Marketing-authorisation holder

GlaxoSmithKline Trading Services

Revision1
Date of issue of marketing authorisation valid throughout the European Union02/12/2015

Contact address:

GlaxoSmithKline Trading Services
Currabinny
Carrigaline
County Cork
Ireland

Product information

Product information

25/02/2016  Nucala -EMEA/H/C/003860 -IA/0001

Name Language First published Last updated
Nucala : EPAR - Product Information EN = English 2015-12-03 2016-04-15
Nucala : EPAR - Product Information EN = English 2015-12-03 2016-04-15
Nucala : EPAR - Product Information EN = English 2015-12-03 2016-04-15
Nucala : EPAR - Product Information EN = English 2015-12-03 2016-04-15
Nucala : EPAR - Product Information EN = English 2015-12-03 2016-04-15
Nucala : EPAR - Product Information EN = English 2015-12-03 2016-04-15
Nucala : EPAR - Product Information EN = English 2015-12-03 2016-04-15
Nucala : EPAR - Product Information EN = English 2015-12-03 2016-04-15
Nucala : EPAR - Product Information EN = English 2015-12-03 2016-04-15
Nucala : EPAR - Product Information EN = English 2015-12-03 2016-04-15
Nucala : EPAR - Product Information EN = English 2015-12-03 2016-04-15
Nucala : EPAR - Product Information EN = English 2015-12-03 2016-04-15
Nucala : EPAR - Product Information EN = English 2015-12-03 2016-04-15
Nucala : EPAR - Product Information EN = English 2015-12-03 2016-04-15
Nucala : EPAR - Product Information EN = English 2015-12-03 2016-04-15
Nucala : EPAR - Product Information EN = English 2015-12-03 2016-04-15
Nucala : EPAR - Product Information EN = English 2015-12-03 2016-04-15
Nucala : EPAR - Product Information EN = English 2015-12-03 2016-04-15
Nucala : EPAR - Product Information EN = English 2015-12-03 2016-04-15
Nucala : EPAR - Product Information EN = English 2015-12-03 2016-04-15
Nucala : EPAR - Product Information EN = English 2015-12-03 2016-04-15
Nucala : EPAR - Product Information EN = English 2015-12-03 2016-04-15
Nucala : EPAR - Product Information EN = English 2015-12-03 2016-04-15
Nucala : EPAR - Product Information EN = English 2015-12-03 2016-04-15
Nucala : EPAR - Product Information EN = English 2015-12-03 2016-04-15

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
Nucala : EPAR - All Authorised presentations EN = English 2015-12-03  
Nucala : EPAR - All Authorised presentations EN = English 2015-12-03  
Nucala : EPAR - All Authorised presentations EN = English 2015-12-03  
Nucala : EPAR - All Authorised presentations EN = English 2015-12-03  
Nucala : EPAR - All Authorised presentations EN = English 2015-12-03  
Nucala : EPAR - All Authorised presentations EN = English 2015-12-03  
Nucala : EPAR - All Authorised presentations EN = English 2015-12-03  
Nucala : EPAR - All Authorised presentations EN = English 2015-12-03  
Nucala : EPAR - All Authorised presentations EN = English 2015-12-03  
Nucala : EPAR - All Authorised presentations EN = English 2015-12-03  
Nucala : EPAR - All Authorised presentations EN = English 2015-12-03  
Nucala : EPAR - All Authorised presentations EN = English 2015-12-03  
Nucala : EPAR - All Authorised presentations EN = English 2015-12-03  
Nucala : EPAR - All Authorised presentations EN = English 2015-12-03  
Nucala : EPAR - All Authorised presentations EN = English 2015-12-03  
Nucala : EPAR - All Authorised presentations EN = English 2015-12-03  
Nucala : EPAR - All Authorised presentations EN = English 2015-12-03  
Nucala : EPAR - All Authorised presentations EN = English 2015-12-03  
Nucala : EPAR - All Authorised presentations EN = English 2015-12-03  
Nucala : EPAR - All Authorised presentations EN = English 2015-12-03  
Nucala : EPAR - All Authorised presentations EN = English 2015-12-03  
Nucala : EPAR - All Authorised presentations EN = English 2015-12-03  
Nucala : EPAR - All Authorised presentations EN = English 2015-12-03  
Nucala : EPAR - All Authorised presentations EN = English 2015-12-03  
Nucala : EPAR - All Authorised presentations EN = English 2015-12-03  

Pharmacotherapeutic group

Drugs for obstructive airway diseases

Therapeutic indication

Nucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adult patients.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Nucala : EPAR - Procedural steps taken and scientific information after authorisation EN = English 2016-04-15  

Initial marketing-authorisation documents

Name Language First published Last updated
Nucala : EPAR - Public assessment report EN = English 2015-12-03 2016-01-12
CHMP summary of positive opinion Nucala EN = English 2015-09-25  

Authorised

This medicine is approved for use in the European Union