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07-Mar-2019

Chiesi extrafine formulation triple therapy combination Trimbow® (beclometasone/formoterol/glycopyrronium) gains expanded Chronic Obstructive Pulmonary Disease (COPD) indication in Europe

Chiesi extrafine formulation triple therapy combination Trimbow® (beclometasone/formoterol/glycopyrronium) gains expanded Chronic Obstructive Pulmonary Disease (COPD) indication in Europe

Trimbow® (beclometasone [BDP]/formoterol [FF]/glycopyrronium [G]) is now also indicated for patients with moderate to severe COPD not adequately treated with long acting dual bronchodilation (long-acting beta2- agonist [LABA] / long-acting muscarinic antagonist [LAMA])1

Manchester, March 6, 2019 - Chiesi, an international research-focused healthcare Group (Chiesi Group) announces that the European Commission has authorised an expanded label for Trimbow® (BDP/FF/G), recognising its effect on exacerbations and symptoms in patients with moderate to severe chronic obstructive pulmonary disease (COPD) not adequately treated with dual bronchodilation or with an inhaled corticosteroid (ICS) and a LABA.

While bronchodilation is recognised as the foundation of COPD therapy, many patients may continue to struggle with symptoms and exacerbations over time. The expanded indication for Trimbow reflects the evidence supporting its potential benefits in moderate to severe COPD patients who are not adequately treated by a combination of a LABA and a LAMA, 2 giving them the option of taking Trimbow fixed tripletherapy.

“We are delighted that Trimbow is now available for patients with moderate to severe COPD requiring a step up from dual bronchodilation,” commented Alessandro Chiesi, Head of Region Europe, Chiesi Group.

The label update is based on data from the TRIBUTE study,2 published last year in The Lancet, which showed that Trimbow reduced moderate-to-severe exacerbation rate compared with LAMA/LABA Ultibro® Breezhaler (indacaterol / glycopyrronium) in patients with severe / very severe COPD, the study’s primary endpoint. A comparable safety profile was also shown.

 

Trimbow updated indication:

Maintenance treatment in adult patients with moderate to severe COPD who are not adequately treated by a combination of an ICS and a LABA or a combination of a LABA and a LAMA (for effects on symptoms control and prevention of exacerbations see section 5.1 of the Summary of Product Characteristics [SPC]). It was originally approved in the European Union (EU) in July 2017 as maintenance treatment in adult patients with moderate to severe COPD who are not adequately treated by a combination of an ICS and a LABA (for effects on prevention of exacerbations and symptoms control see section 5.1 of the SPC).

 

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Notes to Editors About COPD

COPD is a respiratory disease characterised by a persistent bronchial obstruction, associated with an increased chronic inflammatory response of the airways to noxious particles or gas. The classic symptoms associated with COPD are dyspnoea, chronic coughing and chronic productive sputum. In some cases, an acute worsening of the above-mentioned symptoms may occur, triggering COPD exacerbation. A double mechanism is at work in the bronchial obstruction in COPD patients: on one hand, an inflammation of the small airways together with the thickening of the airway walls and increased airflow resistance may occur. On the other, a progressive destruction of lung parenchyma (emphysema) associated with the loss of elastic retraction of the lung may take place. It is important to underline that both mechanisms may coexist, leading to airflow reduction throughout the lungs.

 

About Trimbow (BDP/FF/G)

Trimbow is the first licensed pressurised metered-dose inhaler (pMDI) triple therapy in Europe containing ICS / LABA / LAMA. Trimbow is available in Europe as a pMDI to be marketed with an approved indication for maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2- agonist or a combination of a long-acting beta2-agonist and a long-acting muscarinic antagonist (for effects on symptoms control and prevention of exacerbations, please refer to section 5.1 of the SPC). Each Trimbow 87/5/9 pMDI delivered dose contains 87micrograms (mcg) of beclometasone, 5mcg of formoterol and 9mcg of glycopyrronium. This is equivalent to a metered dose of 100mcg beclometasone, 6mcg formoterol and 10mcg glycopyrronium.

 

About TRIBUTE

TRIBUTE is a randomised, parallel-group, double-blind, double-dummy, active-controlled Phase 3b study, involving 1532 patients and conducted in 187 sites across 17 countries. This study was the first to compare specifically a fixed triple therapy with a fixed dual bronchodilator combination, both in single inhalers, in terms of reducing moderate-to-severe exacerbations over a 52-week treatment period.

 

About Chiesi Group

Based in Parma, Italy, Chiesi Farmaceutici is an international research-focused Healthcare Group, with over 80 years of experience in the pharmaceutical industry, and with presence in 27 countries. Chiesi researches, develops and markets innovative drugs in the respiratory therapeutics, specialist medicine and rare disease areas. Its R&D organisation is headquartered in Parma (Italy), and integrated with 6 other key R&D groups in France, the USA, the UK and Sweden to advance Chiesi's pre-clinical, clinical and registration programmes. Chiesi employs over 5,700 people. For more information, please visit www.chiesi.com. Chiesi Limited is the UK affiliate of Chiesi Farmaceutici S.p.A. It is headquartered in Manchester. For more information visit www.chiesi.uk.com.

 

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References

1 Trimbow pMDI 87/5/9 Summary of Product Characteristics. Available at: www.medicines.org.uk/emc/product/761/smpc

2 Papi A, et al. Extrafine inhaled triple therapy versus dual bronchodilator therapy in chronic obstructive pulmonary disease (TRIBUTE): a double-blind, parallel group, randomised controlled trial, Lancet. 2018. Available here: https://doi.org/10.1016/S0140- 6736(18)30206-X

 

UK-TRI-1900074 | March 2019

Editor Details

Last Updated: 08-Mar-2019