CHMP Recommends Triple Combo for COPD Maintenance

Troy Brown, RN

May 19, 2017

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorization for Trimbow (Chiesi Farmaceutici S.p.A., Italy), a combination of three inhaled medications, for the maintenance treatment of adults with moderate to severe chronic obstructive pulmonary disease (COPD) who do not respond adequately to a combination of an inhaled corticosteroid and a long-acting β2-agonist.

Trimbow (beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium bromide) is an inhaled formulation containing a glucocorticoid, a long-acting β2 receptor agonist, and a long-acting muscarinic antagonist, respectively.

Beclometasone reduces lung inflammation, whereas formoterol and glycopyrronium relax bronchial smooth muscle and dilate the airways.

The triple-drug combination will be formulated as a pressurized metered-dose inhaler that administers a solution with a nominal dose per actuation of 87 μg/5 μg/9 μg of the active substances, respectively.

The inhaled combination relieves and prevents symptoms, including shortness of breath, wheezing, and cough, and reduces flare-ups of COPD symptoms. The most frequent adverse events are oral candidiasis, muscle spasm, and dry mouth.

The summary of product characteristics will provide detailed recommendations for the use of this product; it will be published in all official European Union languages in the European public assessment report after the European Commission grants marketing authorization.

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