o

EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/488502/2012

EMEA/H/C/002691

EPAR summary for the public

Enurev Breezhaler

glycopyrronium bromide

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

What is Enurev Breezhaler?

Enurev Breezhaler is a medicine that contains the active substance glycopyrronium bromide. It is available as capsules containing a powder for inhalation.

What is Enurev Breezhaler used for?

Enurev Breezhaler is used 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. Enurev Breezhaler is used for maintenance (regular) treatment.

The medicine can only be obtained with a prescription.

How is Enurev Breezhaler used?

Enurev Breezhaler capsules are only used with the Enurev Breezhaler inhaler and must not be swallowed. To take a dose, the patient places a capsule into the inhaler and breathes in through the mouth the powder contained in the capsule. For detailed information on how to use the inhaler correctly, see the instructions in the package leaflet.

The recommended dose is one capsule once a day at the same time each day. Patients should not take more than one capsule in a day.

7 Westferry Circus • Canary Wharf • London E14 4HB • United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8416 E-mail info@ema.europa.eu Website www.ema.europa.eu

© European Medicines Agency, 2012. Reproduction is authorised provided the source is acknowledged.

Enurev Breezhaler is an anticholinergic bronchodilator. This means that it widens the airways by blocking some receptors in muscle cells in the lungs called muscarinic receptors, which control the contraction of muscles. When the active substance in Enurev Breezhaler, glycopyrronium bromide, is inhaled, it causes the muscles of the airways to relax, helping to keep the airways open and allowing the patient to breathe more easily.

How has Enurev Breezhaler been studied?

The effects of Enurev Breezhaler were first tested in experimental models before being studied in humans.

Enurev Breezhaler has been studied in two main studies involving a total of 1,888 patients with COPD, where Enurev Breezhaler was compared with placebo (a dummy treatment). In both studies, the main measure of effectiveness was how Enurev Breezhaler improved patients' forced expiratory volumes (FEVi, the maximum volume of air a person can breathe out in one second) after 12 weeks of treatment.

What benefit has Enurev Breezhaler shown during the studies?

Enurev Breezhaler was more effective than placebo at improving how well the lungs work in patients with COPD: after 12 weeks of treatment, the increase in FEV₁ with Enurev Breezhaler was 97 ml more than with placebo in the first study and 108 ml more in the second study.

What is the risk associated with Enurev Breezhaler?

The most common side effects with Enurev Breezhaler (seen in between 1 and 10 patients in 100) are dry mouth, nasopharyngitis (inflammation of the nose and throat), insomnia (difficulty sleeping) and gastroenteritis (diarrhoea and vomiting). For the full list of all side effects reported with Enurev Breezhaler, see the package leaflet.

Enurev Breezhaler must not be used in people who are hypersensitive (allergic) to glycopyrronium bromide or any of the other ingredients.

Why has Enurev Breezhaler been approved?

The CHMP noted that Enurev Breezhaler had a modest but relevant benefit for patients in terms of improving lung function, and was also seen to improve the symptoms of COPD. The CHMP also noted that the fact that the medicine is used once a day may help patients to comply with their treatment. In addition, there were no major safety concerns with Enurev Breezhaler, with side effects being similar to other anticholinergic bronchodilator medicines. Therefore, the CHMP decided that Enurev Breezhaler's benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe use of Enurev Breezhaler?

As anticholinergic bronchodilator medicines may have an effect on the heart and blood vessels, the company will continue to closely monitor the medicine's cardiovascular effects and will carry out a further study in patients to identify any potential risks.

Enurev Breezhaler

The European Commission granted a marketing authorisation valid throughout the European Union for Enurev Breezhaler on 28 September 2012w.

The full EPAR for Enurev Breezhaler can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. For more information about treatment with Enurev Breezhaler, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 07-2012.

Enurev Breezhaler

Page 3/3