Anoro

umeclidinium bromide / vilanterol

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

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

What is Anoro and what is it used for?

Anoro is a medicine that contains the active substances umeclidinium bromide and vilanterol. It is used as a maintenance (regular) treatment to relieve the symptoms of chronic obstructive pulmonary disease (COPD) in adults. COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty breathing.

How is Anoro used?

Anoro can only be obtained with a prescription. It is available as an inhalation powder in a portable inhaler device. The inhaler delivers 22 micrograms of vilanterol and 55 micrograms of umeclidinium (as umeclidinium bromide) with each inhalation.

The recommended dose is one inhalation per day at the same time each day. For detailed information on how to use the inhaler correctly, see the instructions in the package leaflet.

How does Anoro work?

The active substances in Anoro, umeclidinium and vilanterol, work in different ways to widen the airways and improve breathing in COPD.

Anoro contains two active substances. Vilanterol is a long-acting beta-2 adrenergic agonist. It works by attaching to beta-2 adrenergic receptors found in the muscle cells of many organs including the airways in the lungs. When inhaled, vilanterol reaches the receptors in the airways and activates them. This causes the muscles of the airways to relax.

Umeclidinium is a muscarinic receptor antagonist. It works by blocking other receptors called muscarinic receptors, which control the contraction of muscles. When umeclidinium is inhaled, it also causes the muscles of the airways to relax.

The combined action of the two active substances helps to keep the airways open and allows the patient to breathe more easily. Muscarinic receptor antagonists and long-acting beta-2 agonists are commonly combined in the management of COPD.

What benefits of Anoro have been shown in studies?

The combination umeclidinium and vilanterol was investigated in five main studies involving over 5,600 patients. Two studies compared the fixed-dose combination of umeclidinium and vilanterol (one corresponding to Anoro and one higher-dose combination) with vilanterol alone, umeclidinium alone and placebo (a dummy treatment). One study used the umeclidinium 55 micrograms /vilanterol 22 micrograms dose (Anoro), while the second study used a higher dose of umeclidinium 113 micrograms/vilanterol 22 micrograms.

Two other studies compared the above fixed dose-combinations of umeclidinium and vilanterol with another COPD medicine called tiotropium and one study compared only the lower dose of umeclidinium and vilanterol (55 micrograms/ 22 micrograms) against tiotropium.

In all five studies, the main measure of effectiveness was based on changes in the patients’ forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second).

Results showed that Anoro improved lung function by an average FEV1 of 167 ml more than placebo after 24 weeks of treatment. Anoro also increased FEV1 by an average of up to 95 ml more than vilanterol alone and by 52 ml more than umeclidinium bromide alone. The average increase in FEV1 with Anoro was 60, 90 and 112 ml more than with tiotropium after 24 weeks of treatment in the three studies where Anoro was compared with tiotropium.

Anoro was also shown to improve breathlessness when compared with placebo.

The higher dose combination of umeclidinium (113 micrograms) and vilanterol (22 micrograms) did not consistently lead to better improvements in lung function than the lower dose combination (55 micrograms/22 micrograms) to justify its use.

What are the risks associated with Anoro?

The most common side effect with Anoro (seen in between 1 and 10 patients in 100) are upper respiratory tract infections (colds), urinary tract infections (infection of the structures that carry urine), pharyngitis (inflammation of the throat), sinusitis (inflammation of the sinuses), nasopharyngitis (inflammation of the nose and throat), headache, cough, ororpharyngeal pain (pain in the mouth and throat), constipation and dry mouth.

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

Why is Anoro approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Anoro’s benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP concluded that Anoro was shown to be effective at improving lung function and the symptoms of COPD when compared with placebo or the single components as well as with tiotropium. The CHMP also noted that there were no major safety concerns with Anoro, with side effects being manageable, although the long-term safety data so far are limited. To investigate this further the CHMP recommended that a study be carried out.

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

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

As medicines of the same class as Anoro may have an effect on the heart and blood vessels in the brain, the company will continue to closely monitor the medicine’s effects on the heart and brain and will carry out further long-term studies in patients to identify any potential risks.

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

Other information about Anoro

The European Commission granted a marketing authorisation valid throughout the European Union for Anoro on 8 May 2014.

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

Name Language First published Last updated
Anoro : EPAR - Summary for the public BG = bălgarski 2014-06-16  
Anoro : EPAR - Summary for the public ES = español 2014-06-16  
Anoro : EPAR - Summary for the public CS = čeština 2014-06-16  
Anoro : EPAR - Summary for the public DA = dansk 2014-06-16  
Anoro : EPAR - Summary for the public DE = Deutsch 2014-06-16  
Anoro : EPAR - Summary for the public ET = eesti keel 2014-06-16  
Anoro : EPAR - Summary for the public EL = elliniká 2014-06-16  
Anoro : EPAR - Summary for the public EN = English 2014-06-16  
Anoro : EPAR - Summary for the public FR = français 2014-06-16  
Anoro : EPAR - Summary for the public IT = italiano 2014-06-16  
Anoro : EPAR - Summary for the public LV = latviešu valoda 2014-06-16  
Anoro : EPAR - Summary for the public LT = lietuvių kalba 2014-06-16  
Anoro : EPAR - Summary for the public HU = magyar 2014-06-16  
Anoro : EPAR - Summary for the public MT = Malti 2014-06-16  
Anoro : EPAR - Summary for the public NL = Nederlands 2014-06-16  
Anoro : EPAR - Summary for the public PL = polski 2014-06-16  
Anoro : EPAR - Summary for the public PT = português 2014-06-16  
Anoro : EPAR - Summary for the public RO = română 2014-06-16  
Anoro : EPAR - Summary for the public SK = slovenčina 2014-06-16  
Anoro : EPAR - Summary for the public SL = slovenščina 2014-06-16  
Anoro : EPAR - Summary for the public FI = suomi 2014-06-16  
Anoro : EPAR - Summary for the public SV = svenska 2014-06-16  
Anoro : EPAR - Summary for the public HR = Hrvatski 2014-06-16  
Name Language First published Last updated
Anoro : EPAR - Risk-management-plan summary (English only) 2014-06-16  

This EPAR was last updated on 29/09/2016 .

Authorisation details

Product details

Product details for Anoro
NameAnoro
Agency product numberEMEA/H/C/002751
Active substance

umeclidinium bromide / vilanterol trifenatate

International non-proprietary name (INN) or common name

umeclidinium bromide / vilanterol

Therapeutic area Pulmonary Disease, Chronic Obstructive
Anatomical therapeutic chemical (ATC) code R03AL03
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 Anoro
Marketing-authorisation holder

Glaxo Group Ltd

Revision5
Date of issue of marketing authorisation valid throughout the European Union08/05/2014

Contact address:

Glaxo Group Ltd
Berkeley Avenue
Greenford
Middlesex UB6 0NN
United Kingdom

Product information

Product information

22/09/2016  Anoro -EMEA/H/C/002751 -PSUSA/10264/201512

Name Language First published Last updated
Anoro : EPAR - Product Information EN = English 2014-06-16 2016-09-29
Anoro : EPAR - Product Information EN = English 2014-06-16 2016-09-29
Anoro : EPAR - Product Information EN = English 2014-06-16 2016-09-29
Anoro : EPAR - Product Information EN = English 2014-06-16 2016-09-29
Anoro : EPAR - Product Information EN = English 2014-06-16 2016-09-29
Anoro : EPAR - Product Information EN = English 2014-06-16 2016-09-29
Anoro : EPAR - Product Information EN = English 2014-06-16 2016-09-29
Anoro : EPAR - Product Information EN = English 2014-06-16 2016-09-29
Anoro : EPAR - Product Information EN = English 2014-06-16 2016-09-29
Anoro : EPAR - Product Information EN = English 2014-06-16 2016-09-29
Anoro : EPAR - Product Information EN = English 2014-06-16 2016-09-29
Anoro : EPAR - Product Information EN = English 2014-06-16 2016-09-29
Anoro : EPAR - Product Information EN = English 2014-06-16 2016-09-29
Anoro : EPAR - Product Information EN = English 2014-06-16 2016-09-29
Anoro : EPAR - Product Information EN = English 2014-06-16 2016-09-29
Anoro : EPAR - Product Information EN = English 2014-06-16 2016-09-29
Anoro : EPAR - Product Information EN = English 2014-06-16 2016-09-29
Anoro : EPAR - Product Information EN = English 2014-06-16 2016-09-29
Anoro : EPAR - Product Information EN = English 2014-06-16 2016-09-29
Anoro : EPAR - Product Information EN = English 2014-06-16 2016-09-29
Anoro : EPAR - Product Information EN = English 2014-06-16 2016-09-29
Anoro : EPAR - Product Information EN = English 2014-06-16 2016-09-29
Anoro : EPAR - Product Information EN = English 2014-06-16 2016-09-29
Anoro : EPAR - Product Information EN = English 2014-06-16 2016-09-29
Anoro : EPAR - Product Information EN = English 2014-06-16 2016-09-29

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
Anoro : EPAR - All Authorised presentations EN = English 2014-06-16  
Anoro : EPAR - All Authorised presentations EN = English 2014-06-16  
Anoro : EPAR - All Authorised presentations EN = English 2014-06-16  
Anoro : EPAR - All Authorised presentations EN = English 2014-06-16  
Anoro : EPAR - All Authorised presentations EN = English 2014-06-16  
Anoro : EPAR - All Authorised presentations EN = English 2014-06-16  
Anoro : EPAR - All Authorised presentations EN = English 2014-06-16  
Anoro : EPAR - All Authorised presentations EN = English 2014-06-16  
Anoro : EPAR - All Authorised presentations EN = English 2014-06-16  
Anoro : EPAR - All Authorised presentations EN = English 2014-06-16  
Anoro : EPAR - All Authorised presentations EN = English 2014-06-16  
Anoro : EPAR - All Authorised presentations EN = English 2014-06-16  
Anoro : EPAR - All Authorised presentations EN = English 2014-06-16  
Anoro : EPAR - All Authorised presentations EN = English 2014-06-16  
Anoro : EPAR - All Authorised presentations EN = English 2014-06-16  
Anoro : EPAR - All Authorised presentations EN = English 2014-06-16  
Anoro : EPAR - All Authorised presentations EN = English 2014-06-16  
Anoro : EPAR - All Authorised presentations EN = English 2014-06-16  
Anoro : EPAR - All Authorised presentations EN = English 2014-06-16  
Anoro : EPAR - All Authorised presentations EN = English 2014-06-16  
Anoro : EPAR - All Authorised presentations EN = English 2014-06-16  
Anoro : EPAR - All Authorised presentations EN = English 2014-06-16  
Anoro : EPAR - All Authorised presentations EN = English 2014-06-16  
Anoro : EPAR - All Authorised presentations EN = English 2014-06-16  
Anoro : EPAR - All Authorised presentations EN = English 2014-06-16  

Pharmacotherapeutic group

Drugs for obstructive airway diseases

Therapeutic indication

Anoro is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Anoro : EPAR - Public assessment report EN = English 2014-06-16  
CHMP summary of positive opinion for Anoro EN = English 2014-02-21  

Authorised

This medicine is approved for use in the European Union