What is Revinty Ellipta - fluticasone and vilanterol?
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 adolescents from 12 years of age, in whom the disease is not adequately controlled with other asthma medications called corticosteroids and "short-acting beta2-agonists", assumed by inhalation, when the use of a combination medicine is considered appropriate. Revinty Ellipta is also used to alleviate symptoms of chronic obstructive pulmonary disease (COPD) in adults who have had an exacerbation of the disease in the past despite having undergone regular therapy. COPD is a chronic disease in which the airways and pulmonary alveoli are damaged or blocked, resulting in difficulty breathing. This medicine is identical to Relvar Ellipta, already authorized in the European Union (EU). The company that makes Relvar Ellipta has agreed that the relevant scientific data were also used for Revinty Ellipta ("informed consent").
How is Revinty Ellipta - fluticasone and vilanterol used?
Revinty Ellipta can only be obtained with a prescription. It is available as an inhalation powder contained in a portable inhaler; with each inhalation a predetermined dose of the medicine is given. Revinty Ellipta 92/22 micrograms (92 micrograms of fluticasone furoate and 22 micrograms of vilanterol) can be used to treat both asthma and COPD, while Revinty Ellipta 184/22 micrograms (184 micrograms fluticasone furoate and 22 micrograms vilanterol ) can be used exclusively for the treatment of asthma. The recommended dose is one inhalation per day. In the treatment of asthma, therapy may begin with Revinty Ellipta 92/22 micrograms or Revinty Ellipta 184/22 micrograms, depending on the therapy previously followed by the patient. Patients who start treatment at the lowest dose may resort to the highest dose if the asthma is not adequately controlled. For more information, see the package leaflet.
How does Revinty Ellipta - fluticasone and vilanterol work?
Revinty Ellipta contains two active ingredients. Fluticasone furoate belongs to a group of anti-inflammatory medicines known as corticosteroids. It acts in a similar way to natural corticosteroid hormones: by binding to receptors on different types of immune cells, it reduces the activity of the immune system. This action in turn determines a reduction in the release of substances that participate in the inflammatory process (including histamine), thus helping to keep the airways free and allowing the patient to breathe more easily. Vilanterol is a long-acting beta2-agonist. It works by binding to beta2 receptors in the muscle cells of numerous organs. Once inhaled, vilanterol reaches the receptors in the airways and activates them. In this way it induces the relaxation of the airway muscles, which helps to keep them free, allowing the patient to breathe more easily. Long-acting corticosteroids and beta2-agonists are usually used in combination in the treatment of asthma and COPD.
What benefit has Revinty Ellipta - fluticasone and vilanterol shown during the studies?
In the treatment of asthma, Revinty Ellipta has been studied in three main studies involving over 3 200 patients. In two of these studies, Revinty Ellipta was compared with fluticasone furoate or fluticasone propionate, inhaled powder, used as monotherapy, or with placebo (a dummy treatment). The main measure of effectiveness was based on the evolution of the forced expiratory volume (FEV1, the maximum volume of air that a person is able to exhale in one second) of the patient. After 12 weeks of treatment, Revinty Ellipta 92/22 micrograms improved the mean FEV1 by 36 ml compared to fluticasone furoate and 172 ml compared to placebo. After 24 weeks of treatment, used at a higher dose (184/22 micrograms), he improved FEV1 by 193 ml compared to fluticasone furoate and 210 ml compared to the medicine used for comparison, fluticasone propionate. The third study compared Revinty Ellipta 92/22 micrograms with fluticasone furoate alone: the main measure of effectiveness was the period of time spent without a severe exacerbation of symptoms in patients. Data from this study showed that, over 52 weeks, 12.8% of patients treated with Revinty Ellipta had one or more severe exacerbations compared to 15.9% of patients treated with fluticasone furoate alone. In the treatment of BCPO, 4 main studies were conducted on a total of over 5 500 adults. Two studies compared different doses of Revinty Ellipta with fluticasone furoate and vilanterol, administered separately, and with 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 micrograms improved the mean FEV1 by 115 ml compared to placebo, while the second study showed that Revinty Ellipta 184/22 micrograms improved mean FEV1 by 131 ml compared to placebo.
In two further studies, three different doses of Revinty Ellipta were compared with vilanterol monotherapy: the main measure of effectiveness was the reduction in the number of moderate to severe exacerbations in BCPO patients over 52 weeks (one year) of treatment. All the different dosages of Revinty Ellipta were more effective than vilanterol taken as a single agent in reducing the number of BCPO flare-ups. However, there were no improvements in treatment with Revinty Ellipta 184/22 micrograms compared with treatment with Revinty Ellipta 92/22 micrograms. COPD exacerbations were reduced by 13-34% in patients treated with Revinty Ellipta compared to the group treated with vilanterol alone.
What is the risk associated with Revinty Ellipta - fluticasone and vilanterol?
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). The most serious side effects include pneumonia and fractures (which may affect up to 1 in 10 people), which have been reported more frequently in patients with BCPO than in asthmatics. For the full list of side effects and limitations, see the package leaflet.
Why has Revinty Ellipta - fluticasone and vilanterol been 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 came to the conclusion that Revinty Ellipta (92/22 micrograms and 184/22 micrograms) was shown to be effective in improving FEV1 in asthmatic patients and in reducing the number of asthma exacerbations. This reduction, although modest, was considered clinically relevant and similar to the effects of other long-acting corticosteroid and beta2-agonist inhalation medicines. The Committee also concluded that data from BCPO studies have adequately demonstrated that Revinty Ellipta 92/22 micrograms had a clinically relevant effect on the reduction of COPD exacerbations. As for the safety profile of the medicine, the most frequent side effects with Revinty Ellipta were similar to those seen with other medicines used in the treatment of BCPO and asthma. An increase in the incidence of pneumonia was observed in patients with BCPO, which will be examined in further studies.
What measures are being taken to ensure the safe and effective use of Revinty Ellipta - fluticasone and vilanterol?
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 carry out further studies to examine the risk of pneumonia associated with this medicine compared to other medicines used in the treatment of BCPO and asthma. Further information is available in the summary of the risk management plan.
Other information on Revinty Ellipta - fluticasone and vilanterol
On 2 May 2014, the European Commission issued a marketing authorization for Revinty Ellipta, valid throughout the European Union. For more information about treatment with Revinty Ellipta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 05-2014.
