Indacaterol/glycopyrronium bromide/mometasone

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Indacaterol/glycopyrronium bromide/mometasone
Combination of
IndacaterolUltra-long-acting beta-adrenoceptor agonist
Glycopyrronium bromideMuscarinic anticholinergic
Mometasone furoateCorticosteroid
Clinical data
Trade namesEnerzair Breezhaler, Zimbus Breezhaler
Other namesQVM149
License data
Pregnancy
category
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.[7] It contains indacaterol as acetate, glycopyrronium bromide, and mometasone furoate.[7]

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]

References

  1. ^ https://www.tga.gov.au/sites/default/files/auspar-indacaterol-acetate-glycopyrronium-bromide-mometasone-furoate-210406.pdf Archived 13 June 2021 at the Wayback Machine [bare URL PDF]
  2. ^ "AusPAR: Indacaterol (as acetate) / glycopyrronium (as bromide) / mometasone furoate". Therapeutic Goods Administration (TGA). 21 June 2022. Retrieved 29 April 2023.
  3. ^ "TGA eBS - Product and Consumer Medicine Information Licence". Archived from the original on 13 June 2021. Retrieved 13 June 2021.
  4. ^ "Enerzair Breezhaler (Novartis Pharmaceuticals Australia Pty Ltd)". Therapeutic Goods Administration (TGA). 22 September 2022. Retrieved 29 April 2023.
  5. ^ "Regulatory Decision Summary - Enerzair Breezhaler". Health Canada. 23 October 2014. Archived from the original on 7 June 2022. Retrieved 7 June 2022.
  6. ^ "Enerzair Breezhaler - Summary of Product Characteristics (SmPC)". (emc). 12 May 2021. Archived from the original on 13 June 2021. Retrieved 12 June 2021.
  7. ^ 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. Archived from the original on 22 July 2020. Retrieved 21 July 2020. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  8. ^ a b c "Zimbus Breezhaler EPAR". European Medicines Agency (EMA). 28 April 2020. Archived from the original on 29 September 2020. Retrieved 2 September 2020. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  9. ^ "Enerzair Breezhaler Product information". Union Register of medicinal products. Archived from the original on 5 March 2023. Retrieved 3 March 2023.
  10. ^ "Zimbus Breezhaler Product information". Union Register of medicinal products. Archived from the original on 5 March 2023. Retrieved 3 March 2023.
  11. ^ a b c d e f "First triple combination therapy for asthma with optional electronic sensor". European Medicines Agency (EMA). 30 April 2020. Archived from the original on 22 July 2020. Retrieved 21 July 2020. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  12. ^ 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. Archived from the original on 22 July 2020. Retrieved 21 July 2020.
  13. ^ "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. Archived from the original on 22 July 2020. Retrieved 21 July 2020.
  14. ^ "Zimbus Breezhaler: Pending EC decision". European Medicines Agency (EMA). 30 April 2020. Archived from the original on 22 July 2020. Retrieved 21 July 2020.
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