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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/731724/2013

EMEA/H/C/002673

EPAR summary for the public

Relvar Ellipta

Fluticasone furoate / vilanterol

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

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

What is Relvar Ellipta and what is it used for?

Relvar Ellipta is a medicine that contains the active substances fluticasone furoate and vilanterol. It is used for the regular treatment of asthma in adults and children aged 12 years and above whose disease is not adequately controlled despite treatment with other asthma medicines called corticosteroids and 'short-acting beta-2 agonists' taken by inhalation and for whom a combination product is considered appropriate.

Relvar Ellipta is also used to relieve the symptoms of chronic obstructive pulmonary disease (COPD) in adults who have had exacerbations (flare-ups) of the disease in the past despite regular treatment. COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty in breathing.

How is Relvar Ellipta used?

Relvar Ellipta can only be obtained with a prescription. It is available as an inhalation powder in a portable inhaler device; each inhalation provides a fixed dose of the medicine. Relvar Ellipta 92/22 microgram (92 micrograms of fluticasone furoate and 22 micrograms of vilanterol) can be used for the treatment of both asthma and COPD, while Relvar Ellipta 184/22 microgram (184 micrograms of fluticasone furoate and 22 micrograms of vilanterol) can only be used for the treatment of asthma. The recommended dose is one inhalation a day. For the treatment of asthma, patients may be started with Relvar Ellipta 92/22 microgram or Relvar Ellipta 184/22 microgram depending on their previous

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treatment. In patients started on the lower strength inhaler the higher strength inhaler may be used if the asthma is not adequately controlled. For further information, see the package leaflet.

How does Relvar Ellipta work?

Relvar Ellipta contains two active substances. Fluticasone furoate belongs to a group of antiinflammatory medicines known as corticosteroids. It works in a similar way to naturally occurring corticosteroid hormones, reducing the activity of the immune system by attaching to receptors in various types of immune cell. This leads to a reduction in the release of substances that are involved in the inflammation process, such as histamine, thereby helping to keep the airways clear and allowing the patient to breathe more easily.

Vilanterol is a long-acting beta-2 agonist. It works by attaching to beta-2 receptors found in the muscle cells of many organs. When inhaled, vilanterol reaches the receptors in the airways and activates them. This causes the muscles of the airways to relax, helping to keep the airways open and allowing the patient to breathe more easily.

Corticosteroids and long-acting beta-2 agonists are commonly combined in the management of asthma and COPD.

What benefits of Relvar Ellipta have been shown in studies?

For the treatment of asthma, Relvar Ellipta was investigated in three main studies involving a total of over 3,200 patients. In two of the studies, Relvar Ellipta was compared with fluticasone furoate or fluticasone propionate inhalation powder alone or placebo (dummy treatment). 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). Relvar Ellipta 92/22 microgram improved average FEV₁ by 36 ml more than fluticasone furoate and by 172 ml more than placebo after 12 weeks of treatment; when it was used at a higher dose of 184/22 microgram it improved FEV₁ by 193 ml more than fluticasone furoate and by 210 ml more than the comparator medicine fluticasone propionate after 24 weeks of treatment.

The third study compared Relvar Ellipta 92/22 microgram with fluticasone furoate alone; the main measure of effectiveness was the time patients remained without a severe flare-up of symptoms. Data from this study showed that 12.8% of patients taking Relvar Ellipta had one or more severe flare-ups by 52 weeks compared with 15.9% of patients taking fluticasone furoate alone.

For the treatment of COPD, 4 main studies involving a total of over 5,500 adults were carried out. Two studies compared different doses of Relvar Ellipta with fluticasone furoate and vilanterol given separately and placebo. The main measure of effectiveness was based on the patients' FEV₁ after 24 weeks of treatment. The first study showed that Relvar Ellipta 92/22 microgram improved average FEVi by 115 ml more than placebo, while the second study showed that Relvar Ellipta 184/22 microgram improved average FEV₁ by 131 ml more than placebo.

In two further studies, three different doses of Relvar Ellipta were compared with vilanterol on its own; the main measure of effectiveness was the reduction in the number of moderate and severe flare-ups COPD patients experienced during 52 weeks (one year) of treatment. Relvar Ellipta at all strengths was more effective in reducing the number of COPD flare-ups than vilanterol alone. However, there was no improvement of Relvar Ellipta 184/22 microgram over Relvar Ellipta 92/22 microgram. COPD flare-ups were reduced by between 13 and 34% in those using Relvar Ellipta compared with vilanterol alone.

What are the risks associated with Relvar Ellipta?

The most common side effects with Relvar Ellipta (which may affect more than 1 in 10 people) are headache and nasopharyngitis (inflammation of the nose and throat). More serious side effects include pneumonia and fractures (seen in up to 1 in 10 people), which were reported more often in patients with COPD than those with asthma. For the full list of all side effects reported with Relvar Ellipta, see the package leaflet.

Why is Relvar Ellipta approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Relvar Ellipta's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP concluded that Relvar Ellipta (92 /22 microgram and 184 /22 microgram) was shown to be effective at improving FEV_t in patients with asthma; it was also shown to effectively reduce the number of asthma flare-ups and, although this reduction was small, it was considered to be clinically relevant and similar to the effects of other inhalation medicines combining corticosteroids and long-acting beta-2 agonists. The Committee also concluded that the data derived from the COPD studies adequately demonstrated that Relvar Ellipta 92 /22 microgram had a clinically relevant effect on the reduction of COPD flare-ups. Regarding the safety profile of the medicine, the most frequent side effects reported with Relvar Ellipta were similar to other COPD and asthma treatments; an increased incidence of pneumonia was observed in patients with COPD, and this will be investigated in further studies.

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

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

In addition, the company that markets Relvar Ellipta will conduct further studies to investigate the risk of pneumonia with this medicine in comparison with other COPD and asthma medicines.

Other information about Relvar Ellipta

The European Commission granted a marketing authorisation valid throughout the European Union for Relvar Ellipta on 13 November 2013.

The full EPAR for Relvar Ellipta 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 Relvar Ellipta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 11-2013.

Relvar Ellipta

EMA/731724/2013

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