Indacaterol/glycopyrronium bromide/mometasone

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
  • AU: S4 (Prescription only) [2]
  • UK: POM (Prescription only) [3]
  • EU: Rx-only [4][5]
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.[4] It contains indacaterol as acetate, glycopyrronium bromide, and mometasone furoate.[4]

The most common side effects include worsening of asthma and nasopharyngitis (inflammation in the nose and throat).[4] Other common side effects include upper respiratory tract infection (nose and throat infections) and headache.[4]

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.[6] An optional electronic sensor may also be co-packed with the product.[6] The sensor will be attached to the base of the inhaler to collect data on the use of the inhaler by the patient.[6] The sensor will send the data to an app on a smart phone or other suitable device.[6] It was approved for medical use in the European Union in July 2020.[4][5][7]

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.[4]

Indacaterol is a long-acting beta-2 adrenergic receptor agonist.[4] It relaxes the muscle around the airways into the lungs by activating targets called beta-2 receptors in the muscle cells.[4] This helps to keep the airways open.[4]

Glycopyrronium bromide is a muscarinic receptor antagonist.[4] It blocks muscarinic receptors in muscle cells in the airways.[4] Because these receptors help control the contraction of the airway muscles, blocking them causes the muscles to relax, helping to keep the airways open.[4]

Mometasone is a corticosteroid that has anti-inflammatory effects.[4] It works in a similar way to corticosteroid hormones in the body, reducing the activity of the immune system (the body's defences).[4] 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.[4]

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.[6][8] The CHMP also recommended granting a marketing authorization in the European Union for Zimbus Breezhaler which is a duplicate of Enerzair Breezhaler.[6][9]

Enerzair Breezhaler and Zimbus Breezhaler were approved for medical use in the European Union in July 2020.[4][5][7]

References

  1. ↑ https://www.tga.gov.au/sites/default/files/auspar-indacaterol-acetate-glycopyrronium-bromide-mometasone-furoate-210406.pdf
  2. ↑ "TGA eBS - Product and Consumer Medicine Information Licence".
  3. ↑ "Enerzair Breezhaler - Summary of Product Characteristics (SmPC)". (emc). 12 May 2021. Retrieved 12 June 2021.
  4. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 "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.
  5. 1 2 3 "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.
  6. 1 2 3 4 5 6 "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.
  7. 1 2 "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.
  8. ↑ "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.
  9. ↑ "Zimbus Breezhaler: Pending EC decision". European Medicines Agency (EMA). 30 April 2020. Retrieved 21 July 2020.
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