Elebrato Ellipta

Elebrato Ellipta can only be obtained with a prescription. It is available as an inhalation powder, which the patient inhales through the mouth using a portable inhaler device; the patient should inhale the medicine once a day at around the same time each day. For more information about using Elebrato Ellipta, see the package leaflet or contact your doctor or pharmacist.

Elebrato Ellipta contains three active substances, which work in different ways to widen the airways and improve breathing in COPD.

Fluticasone furoate is a corticosteroid. It works in a similar way to naturally occurring corticosteroid hormones, reducing the activity of the immune system by attaching to receptors (targets) in various types of immune cells. This reduces the release of substances involved in the inflammation process, such as histamine, thereby reducing inflammation and helping to keep the airways clear and allowing the patient to breathe more easily.

Umeclidinium bromide is a muscarinic receptor antagonist. It works by blocking muscarinic receptors, which are involved in the contraction of muscles. When umeclidinium bromide is inhaled, it causes the muscles of the airways to relax.

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

Elebrato Ellipta was shown to improve patients’ breathing and reduce exacerbations (flare-ups) of the disease in 2 main studies.

A study compared Elebrato Ellipta with either vilanterol given with fluticasone furoate or vilanterol with umeclidinium bromide, in 10,355 patients with advanced COPD who were at risk of exacerbations and whose disease was not satisfactorily controlled with a daily maintenance treatment.

In this study, Elebrato Ellipta reduced the rate of moderate and severe exacerbations over one year by 15% compared with treatment with vilanterol and fluticasone furoate, and by 25% compared with treatment with vilanterol and umeclidinium bromide.

Another study involving 1,810 patients whose COPD was not satisfactorily controlled with a daily maintenance treatment for their COPD found Elebrato Ellipta more effective at improving patients’ breathing than an inhaled combination of budesonide, a corticosteroid, and formoterol, a long-acting beta-2 agonist.

After 24 weeks, patients taking Elebrato Ellipta had their FEV1 (the maximum volume of air they could breathe out in one second) improve by 142 ml. This compares with an average reduction of 29 ml seen in patients taking the combination of budesonide and formoterol over the same period. Patients treated with Elebrato Ellipta also reported improved health compared with those treated with the comparator treatment.

The most common side effects with Elebrato Ellipta (which may affect up to 1 in 10 people) are nasopharyngitis (inflammation of the nose and throat), headache and upper respiratory tract infection (nose and throat infection). More serious side effects include pneumonia (which may affect up to 1 in 10 people).

For the full list of side effects and restrictions with Elebrato Ellipta, see the package leaflet.

Elebrato Ellipta improves lung function as well as the quality of life of patients with moderate to severe COPD. Regarding the safety profile of the medicine, the most frequent side effects reported with Elebrato Ellipta were similar to those with the individual active substances of the medicine and are well known. The European Medicines Agency therefore decided that Elebrato 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 Elebrato Ellipta have been included in the summary of product characteristics and the package leaflet.

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

Elebrato Ellipta receiveda marketing authorisation valid throughout the EU on 15 November 2017.