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15-Mar-2019

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 triple therapy.

“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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Last Updated: 19-Mar-2019