The most common side effects include worsening of asthma and nasopharyngitis (inflammation in the nose and throat).[7] Other common side effects include upper respiratory tract infection (nose and throat infections) and headache.[7]
It is the first asthma triple-combination therapy; it consists of a fixed-dose combination of three active substances (indacaterol, glycopyrronium bromide and mometasone furoate) in capsules, to be administered using an inhaler.[11] An optional electronic sensor may also be co-packed with the product.[11] The sensor will be attached to the base of the inhaler to collect data on the use of the inhaler by the patient.[11] The sensor will send the data to an app on a smart phone or other suitable device.[11] It was approved for medical use in the European Union in July 2020.[7][8][12]
Medical uses
Indacaterol/glycopyrronium bromide/mometasone is indicated as a maintenance treatment of asthma in adults not adequately controlled with a maintenance combination of a long acting beta2 agonist and a high dose of an inhaled corticosteroid who experienced one or more asthma exacerbations in the previous year.[7]
Indacaterol is a long-acting beta-2 adrenergic receptor agonist.[7] It relaxes the muscle around the airways into the lungs by activating targets called beta-2 receptors in the muscle cells.[7] This helps to keep the airways open.[7]
Glycopyrronium bromide is a muscarinic receptor antagonist.[7] It blocks muscarinic receptors in muscle cells in the airways.[7] Because these receptors help control the contraction of the airway muscles, blocking them causes the muscles to relax, helping to keep the airways open.[7]
Mometasone is a corticosteroid that has anti-inflammatory effects.[7] It works in a similar way to corticosteroid hormones in the body, reducing the activity of the immune system (the body's defences).[7] Mometasone helps to keep the airways clear by blocking the release of substances, such as histamine, that are involved in inflammation and release of mucus in the airways.[7]
History
In April 2020, the
Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) recommended granting a marketing authorization in the European Union for Enerzair Breezhaler, a new asthma treatment which includes an optional digital sensor.[11][13] The CHMP also recommended granting a marketing authorization in the European Union for Zimbus Breezhaler which is a duplicate of Enerzair Breezhaler.[11][14]
Enerzair Breezhaler and Zimbus Breezhaler were approved for medical use in the European Union in July 2020.[7][8][12]