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EMA Approval

Trixeo Aerosphere

R03AL

抗胆碱能与抗胆碱能结合/三重组合与糖皮质激素

Drugs for obstructive airway diseases

formoterolglycopyrronium bromidebudesonide

Pulmonary Disease, Chronic Obstructive

Basic Information

EMA regulatory identification and product classification information

EMA Identifiers

ATC CodeR03AL
EMA European Classification

Overview Summary

Comprehensive product overview and regulatory summary

Trixeo Aerosphere is a medicine used to treat patients with moderate to severe chronic obstructive pulmonary disease (COPD), a long-term disease in which the airways and air sacs in the lungs become damaged or blocked, leading to difficulty breathing.

Trixeo Aerosphere is used for maintenance (regular) treatment in adults whose disease is not controlled well enough with a combination of inhaled medicines consisting of a long-acting beta-2 agonist plus either a corticosteroid or a long-acting muscarinic antagonist.

Trixeo Aerosphere contains the active substances formoterol, glycopyrronium bromide and budesonide.

Authorisations (1)

EMEA/H/C/004983

AstraZeneca AB,151 85 Sodertalje,Sweden

Authorised

December 9, 2020

Active Substances (4)

formoterol fumarate dihydrate

Glycopyrronium bromide

Budesonide

glycopyrronium bromide

Documents (9)

Trixeo Aerosphere : EPAR - Risk-management-plan summary

January 5, 2021

RISK_MANAGEMENT_PLAN_SUMMARY

Trixeo Aerosphere : EPAR - Procedural steps taken and scientific information after authorisation

July 20, 2021

CHANGES_SINCE_INITIAL_AUTHORISATION

CHMP summary of positive opinion for Trixeo Aerosphere

October 16, 2020

CHANGES_SINCE_INITIAL_AUTHORISATION

Trixeo Aerosphere : EPAR - Public assessment report

January 5, 2021

INITIAL_MARKETING_AUTHORISATION_DOCUMENTS

Trixeo Aerosphere : EPAR - Product information

January 5, 2021

DRUG_PRODUCT_INFORMATION

Trixeo Aerosphere : EPAR - All authorised presentations

January 5, 2021

AUTHORISED_PRESENTATIONS

Trixeo Aerosphere : EPAR - Medicine overview

January 5, 2021

OVERVIEW_DOCUMENT

CHMP summary of positive opinion for Trixeo Aerosphere

October 16, 2020

INITIAL_MARKETING_AUTHORISATION_DOCUMENTS

Trixeo Aerosphere : EPAR - Public assessment report

January 5, 2021

CHANGES_SINCE_INITIAL_AUTHORISATION

Overview Q&A (7)

Question

Other information about Trixeo Aerosphere

Answer

Trixeo Aerosphere received a marketing authorisation valid throughout the EU on 09 December 2020.

Question

How is Trixeo Aerosphere used?

Answer

Trixeo Aerosphere can only be obtained with a prescription. It is available in a portable inhaler device. The recommended dose is two inhalations twice a day (two in the morning and two in the evening). Patients should be shown how to use the inhaler correctly by a doctor or other healthcare professional.

For more information about using Trixeo Aerosphere, see the package leaflet or contact your doctor or pharmacist.

Question

How does Trixeo Aerosphere work?

Answer

Trixeo Aerosphere contains three active substances, which work in different ways to widen the airways and improve breathing in COPD.

Formoterol is a long-acting beta-2 agonist. It attaches to receptors (targets) known as beta-2 receptors in the muscles of the airways. When it attaches to these receptors, it causes the muscles to relax, which keeps the airways open and helps with the patient’s breathing.

Glycopyrronium bromide is a long-acting muscarinic receptor antagonist. This means that it blocks muscarinic receptors in muscle cells in the airways. Because these receptors help control the contraction of muscles, glycopyrronium causes the muscles of the airways to relax, helping to keep the airways open.

Budesonide belongs to a group of anti-inflammatory medicines known as corticosteroids. It works in a similar way to naturally occurring corticosteroid hormones, reducing the activity of the immune system (the body’s natural defences) by attaching to receptors in various types of immune cell. This leads to a reduction in the release of substances that are involved in the inflammation process, such as histamine, thereby keeping the airways clear and allowing the patient to breathe more easily.

Question

What benefits of Trixeo Aerosphere have been shown in studies?

Answer

Two main studies in over 10,000 patients with moderate to very severe COPD have shown that Trixeo Aerosphere is effective at improving patients’ FEV1 (the maximum volume of air they can breathe out in one second) and at reducing the number of exacerbations (flare-ups) of the disease.

In the first study, patients treated with Trixeo Aerosphere for 24 weeks had FEV1 increases of around 147 ml, compared with 125 ml for patients treated with glycopyrronium/formoterol, and 73 ml and 88 ml for patients treated with two different inhalers containing budesonide/formoterol.

The second study, which lasted one year, showed that patients treated with Trixeo Aerosphere had fewer COPD exacerbations (1.08 per year) than patients treated with with glycopyrronium/formoterol (1.42) or budesonide/formoterol (1.24).

Question

What are the risks associated with Trixeo Aerosphere?

Answer

The most common side effects with Trixeo Aerosphere (which may affect up to 1 in 10 people) are pneumonia (lung infection), headache and urinary tract infection.

For the full list of side effects and restrictions of Trixeo Aerosphere, see the package leaflet.

Question

Why is Trixeo Aerosphere authorised in the EU?

Answer

Trixeo Aerosphere improved lung function in patients with moderate to severe COPD, and reduced disease exacerbations. The safety profile of Trixeo Aerosphere is considered similar to that of medicines containing combinations of a corticosteroid, beta-2 agonist and antimuscarinic. The European Medicines Agency therefore decided that Trixeo Aerosphere’s benefits are greater than its risks and it can be authorised for use in the EU.

Question

What measures are being taken to ensure the safe and effective use of Trixeo Aerosphere?

Answer

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Trixeo Aerosphere have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Trixeo Aerosphere are continuously monitored. Side effects reported with Trixeo Aerosphere are carefully evaluated and any necessary action taken to protect patients.

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