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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/198113/2014

EMEA/H/C/003754

EPAR summary for the public

Laventair

umeclidinium bromide / vilanterol

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

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

What is Laventair and what is it used for?

Laventair is a medicine that contains the active substances umeclidinium bromide and vilanterol. It 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. Laventair is used for maintenance (regular) treatment.

How is Laventair used?

Laventair 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 65 micrograms of umeclidinium bromide (equivalent to 55 micrograms of umeclidinium) 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 Laventair work?

Laventair contains two active substances. Vilanterol is a long-acting beta-2 agonist. It works by attaching to beta-2 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.

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Umeclidinium bromide is a muscarinic receptor antagonist. It works by blocking other receptors called muscarinic receptors, which control the contraction of muscles. When umeclidinium bromide 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 Laventair have been shown in studies?

The combination umeclidinium bromide and vilanterol was investigated in four main studies involving over 4,700 patients. Two studies compared two fixed-dose combinations of umeclidinium bromide and vilanterol (one corresponding to Laventair and one higher-dose combination) with vilanterol alone, umeclidinium bromide alone and placebo (a dummy treatment). Two other studies compared the same two fixed dose-combinations of umeclidinium bromide and vilanterol with another COPD medicine called tiotropium. 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 Laventair improved lung function by an average FEV₁ of 167 ml more than placebo after 24 weeks of treatment. Laventair also increased FEV₁ by an average of 95 ml more than vilanterol alone and by 52 ml more than umeclidinium bromide alone. The average increase in FEV1 with Laventair was 90 ml more than with tiotropium after 24 weeks of treatment. Laventair was also shown to improve symptoms such as breathlessness and wheezing.

The results for the higher dose combination of umeclidinium bromide and vilanterol did not consistently show relevant improvements in lung function.

What are the risks associated with Laventair?

The most common side effect with Laventair (seen in 9 patients in 100) is nasopharyngitis (inflammation of the nose and throat).

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

Why is Laventair approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Laventair's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP concluded that Laventair 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 Laventair, with side effects being manageable, although the long-term safety data so far are limited.

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

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

As medicines of the same class as Laventair 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 a further long-term study in patients to identify any potential risks.

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

Other information about Laventair

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

The full EPAR and risk management plan summary for Laventair 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 Laventair, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 05/2014.

Laventair

EMA/198113/2014

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