Indacaterol/glycopyrronium bromide/mometasone
| Combination of | |
|---|---|
| Indacaterol | Ultra-long-acting beta-adrenoceptor agonist |
| Glycopyrronium bromide | Muscarinic anticholinergic |
| Mometasone furoate | Corticosteroid |
| Clinical data | |
| Trade names | Enerzair Breezhaler, Zimbus Breezhaler |
| Other names | QVM149 |
| License data | |
| Pregnancy category |
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| Routes of administration | Inhalation |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| KEGG | |
Indacaterol/glycopyrronium bromide/mometasone, sold under the brand name Enerzair Breezhaler among others, is an inhalable fixed-dose combination medication for the treatment of asthma.[5] It contains indacaterol as acetate, glycopyrronium bromide, and mometasone furoate.[5]
The most common side effects include worsening of asthma and nasopharyngitis (inflammation in the nose and throat).[5] Other common side effects include upper respiratory tract infection (nose and throat infections) and headache.[5]
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.[7] An optional electronic sensor may also be co-packed with the product.[7] The sensor will be attached to the base of the inhaler to collect data on the use of the inhaler by the patient.[7] The sensor will send the data to an app on a smart phone or other suitable device.[7] It was approved for medical use in the European Union in July 2020.[5][6][8]
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.[5]
Indacaterol is a long-acting beta-2 adrenergic receptor agonist.[5] It relaxes the muscle around the airways into the lungs by activating targets called beta-2 receptors in the muscle cells.[5] This helps to keep the airways open.[5]
Glycopyrronium bromide is a muscarinic receptor antagonist.[5] It blocks muscarinic receptors in muscle cells in the airways.[5] Because these receptors help control the contraction of the airway muscles, blocking them causes the muscles to relax, helping to keep the airways open.[5]
Mometasone is a corticosteroid that has anti-inflammatory effects.[5] It works in a similar way to corticosteroid hormones in the body, reducing the activity of the immune system (the body's defences).[5] 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.[5]
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.[7][9] The CHMP also recommended granting a marketing authorization in the European Union for Zimbus Breezhaler which is a duplicate of Enerzair Breezhaler.[7][10]
Enerzair Breezhaler and Zimbus Breezhaler were approved for medical use in the European Union in July 2020.[5][6][8]
References
- ^ https://www.tga.gov.au/sites/default/files/auspar-indacaterol-acetate-glycopyrronium-bromide-mometasone-furoate-210406.pdf [bare URL PDF]
- ^ "TGA eBS - Product and Consumer Medicine Information Licence".
- ^ "Regulatory Decision Summary - Enerzair Breezhaler". Health Canada. 23 October 2014. Retrieved 7 June 2022.
- ^ "Enerzair Breezhaler - Summary of Product Characteristics (SmPC)". (emc). 12 May 2021. Retrieved 12 June 2021.
- ^ a b c d e f g h i j k l m n o p q "Enerzair Breezhaler EPAR". European Medicines Agency (EMA). 28 April 2020. Retrieved 21 July 2020. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ^ a b c "Zimbus Breezhaler EPAR". European Medicines Agency (EMA). 28 April 2020. Retrieved 2 September 2020. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ^ a b c d e f "First triple combination therapy for asthma with optional electronic sensor". European Medicines Agency (EMA). 30 April 2020. Retrieved 21 July 2020. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ^ a b "Novartis receives EC approval for Enerzair Breezhaler, including the first digital companion (sensor and app) that can be prescribed alongside a treatment for uncontrolled asthma in the EU". Novartis (Press release). 7 July 2020. Retrieved 21 July 2020.
- ^ "Novartis receives CHMP positive opinion for Enerzair Breezhaler (QVM149), a potential first-in-class inhaled LABA/LAMA/ICS combination for uncontrolled asthma". Novartis (Press release). 1 May 2020. Retrieved 21 July 2020.
- ^ "Zimbus Breezhaler: Pending EC decision". European Medicines Agency (EMA). 30 April 2020. Retrieved 21 July 2020.
External links
- "Indacaterol". Drug Information Portal. U.S. National Library of Medicine.
- "Glycopyrronium bromide". Drug Information Portal. U.S. National Library of Medicine.
- "Mometasone furoate". Drug Information Portal. U.S. National Library of Medicine.
