This is a summary of the European public assessment report (EPAR) for Revinty 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 Revinty Ellipta.
For practical information about using Revinty Ellipta, patients should read the package leaflet or contact their doctor or pharmacist.
- What is Revinty Ellipta and what is it used for?
Revinty 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.
Revinty 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.
This medicine is the same as Relvar Ellipta, which is already authorised in the European Union (EU). The company that makes Relvar Ellipta has agreed that its scientific data can be used for Revinty Ellipta (‘informed consent’).
- How is Revinty Ellipta used?
Revinty 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. Revinty 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 Revinty 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 Revinty Ellipta 92/22 microgram or Revinty Ellipta 184/22 microgram depending on their previous 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 Revinty Ellipta work?
Revinty Ellipta contains two active substances. Fluticasone furoate belongs to a group of anti-inflammatory 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 Revinty Ellipta have been shown in studies?
For the treatment of asthma, Revinty Ellipta was investigated in three main studies involving a total of over 3,200 patients. In two of the studies, Revinty 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). Revinty 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 Revinty 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 Revinty 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 Revinty 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 Revinty Ellipta 92/22 microgram improved average FEV1 by 115 ml more than placebo, while the second study showed that Revinty Ellipta 184/22 microgram improved average FEV1 by 131 ml more than placebo.
In two further studies, three different doses of Revinty 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. Revinty Ellipta at all strengths was more effective in reducing the number of COPD flare-ups than vilanterol alone. However, there was no improvement of Revinty Ellipta 184/22 microgram over Revinty Ellipta 92/22 microgram. COPD flare-ups were reduced by between 13 and 34% in those using Revinty Ellipta compared with vilanterol alone.
- What are the risks associated with Revinty Ellipta?
The most common side effects with Revinty 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 and restrictions, see the package leaflet.
- Why is Revinty Ellipta approved?
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Revinty Ellipta’s benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP concluded that Revinty Ellipta (92 /22 microgram and 184 /22 microgram) was shown to be effective at improving FEV1 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 Revinty 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 Revinty 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 Revinty Ellipta?
A risk management plan has been developed to ensure that Revinty 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 Revinty Ellipta, including the appropriate precautions to be followed by healthcare professionals and patients.
In addition, the company that markets Revinty Ellipta will conduct further studies to investigate the risk of pneumonia with this medicine in comparison with other COPD and asthma medicines.
Further information can be found in the summary of the risk management plan.
- Other information about Revinty Ellipta
The European Commission granted a marketing authorisation valid throughout the European Union for Revinty Ellipta on 2 May 2014.
For more information about treatment with Revinty Ellipta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
|Name||Language||First published||Last updated|
|Revinty Ellipta : EPAR - Risk-management-plan summary||(English only)||17/06/2014|
This EPAR was last updated on 15/07/2016 .
24/06/2016 Revinty Ellipta -EMEA/H/C/002745 -A31/0010
- 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.
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Adrenergics and other drugs for obstructive airway diseases
Revinty Ellipta is indicated in the regular treatment of asthma in adults and adolescents aged 12 years and older, where use of a combination product (long-acting beta2-agonist and inhaled corticosteroid) is appropriate:
- patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short acting beta2-agonists.
Revinty Ellipta is indicated for the symptomatic treatment of adults with COPD with a FEV1 <70% predicted normal (post-bronchodilator) in patients with an exacerbation history despite bronchodilator therapy.
Changes since initial authorisation of medicine
Initial marketing-authorisation documents
|Name||Language||First published||Last updated|
|Revinty Ellipta : EPAR - Public assessment report||EN = English||17/06/2014|
|CHMP summary of positive opinion for Revinty Ellipta||EN = English||21/03/2014|
This medicine is approved for use in the European Union