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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/110100/2014

EMEA/H/C/002751

EPAR summary for the public

Anoro

umeclidinium bromide / vilanterol

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.

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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 (FEV_t, the maximum volume of air a person can breathe out in one second).

Results showed that Anoro improved lung function by an average FEV_t of 167 ml more than placebo after 24 weeks of treatment. Anoro also increased FEVi 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 FEV_t 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

Anoro

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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.

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

This summary was last updated in 05/2014.

Anoro

EMA/110100/2014