drugs

Anoro - umeclidinium bromide and vilanterol

What is it and what is it used for? Anoro - umeclidinium bromide and vilanterol?

Anoro is a medicine that contains the active substances umeclidinium bromide and vilanterol . It is used as a (regular) maintenance therapy to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). COPD is a chronic disease in which the airways and pulmonary alveoli are damaged or blocked, resulting in difficulty breathing.

How is Anoro - umeclidinium bromide and vilanterol used?

Anoro can only be obtained with a prescription. It is available as an inhalation powder contained in a portable inhaler. The inhaler provides 22 micrograms of vilanterol and 55 micrograms of umeclidinium (in the form of umeclidinium bromide) for each inhalation. The recommended dose is one inhalation per day, at the same time each day. For more information on how to use the inhaler correctly, see the instructions in the package leaflet.

How does Anoro - umeclidinium bromide and vilanterol work?

The active ingredients of Anoro, umeclidinium and vilanterol, act differently to dilate the airways and improve breathing in COPD. Anoro contains two active ingredients: vilanterol is a long-acting beta-2 adrenergic agonist. It works by binding to beta-2 adrenergic receptors in the muscle cells of many organs, including the pulmonary airways. Once inhaled, vilanterol reaches the receptors in the airways and activates them. In this way the airway muscles relax.

Umeclidinium is a muscarinic receptor antagonist. It works by blocking other receptors called "muscarinic receptors", which are responsible for controlling muscle contraction. When inhaled, umeclidinium also has a relaxing effect on the airway muscles. The combined action of the two active ingredients helps keep the airways dilated and allows the patient to breathe more easily. Muscarinic receptor antagonists and long-acting beta-2 agonists are usually combined in the treatment of COPD.

What benefit has Anoro - umeclidinium bromide and vilanterol shown during the studies?

The combination of umeclidinium and vilanterol was examined in five main studies involving over 5, 600 patients. Two studies compared the fixed-dose combination of umeclidinium and vilanterol (one corresponding to Anoro and a combination of higher doses) with vilanterol taken as monotherapy, umeclidinium taken as monotherapy and placebo (a dummy treatment). In one study the dose of umeclidinium 55 micrograms / vilanterol 22 micrograms (Anoro) was used, while in the second study a higher dose was used, consisting of umeclidinium 113 micrograms / vilanterol 22 micrograms. Two other studies compared these two fixed-dose combinations of umeclidinium and vilanterol with another medicine, called tiotropium, used in the treatment of COPD, while a latest study compared only the lowest dose of umeclidinium and vilanterol (55 micrograms / 22 micrograms) with tiotropium. In all five studies the main measure of effectiveness was the improvement in forced expiratory volume (FEV1, the maximum volume of air that a person is able to exhale in one second). Studies showed that, after 24 weeks of treatment, Anoro improved lung function with an average FEV1 of 167 ml more than placebo. Anoro also increased FEV1 on average by 95 ml more than vilanterol monotherapy and 52 ml more than umeclidinium bromide monotherapy. The average increase in FEV1 with Anoro was 60, 90 and 112 ml more than in tiotropium after 24 weeks of treatment in the three studies in which Anoro was compared to tiotropium. Compared to placebo, Anoro has also been shown to improve breathing difficulties. The combination with higher doses of umeclidinium (113 micrograms) and vilanterol (22 micrograms), compared to the combination with lower doses (55 micrograms / 22 micrograms), did not result in improvements in lung function sufficiently coherently to justify its use.

What is the risk associated with Anoro - umeclidinium bromide and vilanterol?

The most common side effects of Anoro (which may affect 1-10 patients in 100) are upper respiratory tract infections (colds), urinary tract infections (infections of the structures responsible for transporting urine), pharyngitis (inflammation of the throat), sinusitis (inflammation of the paranasal sinuses), nasopharyngitis (inflammation of the nose and throat), headache, cough, oropharyngeal pain (pain in the mouth and throat), constipation and dry mouth. For the full list of side effects and limitations, see the package leaflet.

Why has Anoro - umeclidinium bromide and vilanterol been approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Anoro's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP concluded that Anoro was effective in improving lung function and BCPO symptoms when compared with placebo or individually with its components as well as with tiotropium. The CHMP also noted that no major critical issues emerged in relation to the use of Anoro and that undesirable effects are manageable, although only limited data on long-term safety are available to date. The CHMP recommended that a study be carried out to examine this more thoroughly.

What measures are being taken to ensure the safe and effective use of Anoro - umeclidinium bromide and vilanterol?

A risk management plan has been developed to ensure that Anoro 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 Anoro, including the appropriate precautions to be followed by healthcare professionals and patients. Since medicines belonging to the same class as Anoro may have effects on the heart and blood vessels in the brain, the company will continue to closely monitor the cardiac and cerebral effects of the medicine and will carry out other long-term studies on patients to identify potential risks. Further information is available in the summary of the risk management plan.

Other information on Anoro - umeclidinium bromide and vilanterol

On 8 May 2014, the European Commission issued a marketing authorization for Anoro, valid throughout the European Union. For more information on Anoro therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 05/2014