Revinty Ellipta | European Medicines Agency (EMA)

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Overview

Revinty Ellipta is an inhaler for treating asthma and chronic obstructive pulmonary disease (COPD). In asthma, it is used for regular treatment of patients from 12 years of age:

whose symptoms are not controlled with an inhaled corticosteroid and an inhaled short-acting beta-2 agonist;
whose symptoms are adequately controlled with both inhaled corticosteroids and a long-acting beta-2 agonist.

In COPD, it is used in adults who have flare-ups of the disease despite regular bronchodilator treatment (treatment to widen the airways).

Revinty Ellipta contains the active substances fluticasone furoate and vilanterol.

This medicine is the same as Relvar Ellipta, which is already authorised in the EU. The company that makes Relvar Ellipta has agreed that its scientific data can be used for Revinty Ellipta (‘informed consent’).

Relvar Ellipta is available as an inhaler in two strengths (92/22 micrograms and 184/22 micrograms). The doctor will decide which inhaler the patient should use. The dose is one inhalation (‘puff’) into the mouth once a day at the same time each day.

Revinty Ellipta can only be obtained with a prescription. For more information about using Revinty Ellipta, see the package leaflet or contact your doctor or pharmacist.

Revinty Ellipta contains two active substances that work in different ways to improve breathing in patients with asthma and COPD.

Fluticasone furoate is a corticosteroid. It works on various types of immune cells, blocking the release of substances involved in inflammation. This reduces inflammation in the airways and improves the patient’s breathing.

Vilanterol is a long-acting beta-2 agonist. It attaches to beta-2 receptors in the airways and causes the muscles of the airways to relax and widen, allowing the patient to breathe more easily.

Asthma

Three studies in over 3,200 patients showed that Revinty Ellipta improves breathing and reduces flare- ups in patients with persistent asthma.

In two of the studies, Revinty Ellipta 92/22 increased the volume of air a patient could breathe out in one second (FEV1) by 36 ml more than fluticasone furoate alone and 172 ml more than placebo (a dummy treatment). Revinty Ellipta 184/22 also improved FEV1by 193 ml more than fluticasone furoate and 210 ml more than another inhaler containing fluticasone propionate.

In a third study, fewer patients taking Revinty Ellipta 92/22 had at least one severe flare-up after a year of treatment than those taking fluticasone furoate alone (13% versus 16%).

A fourth study in 1,522 patients showed that Revinty Ellipta was as effective as another medicine containing a corticosteroid (fluticasone propionate) and a long-acting beta-2 agonist (salmeterol). These patients were already well controlled with the comparator medicine and Revinty Ellipta treatment was able to maintain their FEV1.

COPD

Four studies in over 5,500 patients showed that Revinty Ellipta improves breathing and reduces flare ups of symptoms in patients with COPD.

The first study showed that Revinty Ellipta 92/22 improved average FEV1by 115 ml more than placebo, and a second study showed that Revinty Ellipta 184/22 improved average FEV1by 131 ml more than placebo.

In two further studies, Revinty Ellipta reduced the number of flare-ups by between 13 and 34% more than vilanterol alone.

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 side effects of Revinty Ellipta, see the package leaflet.

Revinty Ellipta improves breathing and reduces flare ups of symptoms in patients with asthma and COPD. Regarding its safety, the most frequent side effects reported with Revinty Ellipta were similar to those seen with other COPD and asthma treatments; an increased incidence of pneumonia was observed in patients with COPD.

The European Medicines Agency concluded that Revinty Ellipta’s benefits are greater than its risks and it can be authorised for use in the EU.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Revinty Ellipta have also been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Revinty Ellipta are continuously monitored. Side effects reported with Revinty Ellipta are carefully evaluated and any necessary action taken to protect patients.

Revinty Ellipta received a marketing authorisation valid throughout the EU on 2 May 2014.

English (EN)
(83 KB – PDF)

First published: 17/06/2014Last updated: 17/05/2018

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English (EN)
(678.99 KB – PDF)

First published: 17/06/2014Last updated: 06/10/2022

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Product information

English (EN)
(1.36 MB – PDF)

First published: 17/06/2014Last updated: 03/09/2024

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Latest procedure affecting product information:
WS2683

04/07/2024

This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

Product information documents contain:

summary of product characteristics (annex I);
manufacturing authorisation holder responsible for batch release (annex IIA);
conditions of the marketing authorisation (annex IIB);
labelling (annex IIIA);
package leaflet (annex IIIB).

English (EN)
(21.36 KB – PDF)

First published: 17/06/2014Last updated: 17/06/2014

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Product details

Name of medicine

Revinty Ellipta

Active substance

fluticasone furoate
vilanterol trifenatate

International non-proprietary name (INN) or common name

fluticasone furoate
vilanterol

Therapeutic area (MeSH)

Asthma

Anatomical therapeutic chemical (ATC) code

R03AK10

Pharmacotherapeutic group

Adrenergics and other drugs for obstructive airway diseases

Therapeutic indication

Asthma Indication

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.

COPD Indication

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.

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