EU Panel Backs Two Triple Combo Drugs for COPD Maintenance

Megan Brooks

February 23, 2018

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorization for two triple-drug combination inhaled medicines for adults with chronic obstructive pulmonary disease (COPD).

CHF 5993 and Trydonis, from Chiesi Farmaceutici SpA, Italy, combine an inhaled glucocorticoid (beclometasone dipropionate), a long-acting beta-2 receptor agonist (formoterol fumarate dihydrate), and a long-acting muscarinic antagonist (glycopyrronium bromide).

The triple-drug combinations will be formulated for delivery via a pressurized metered-dose inhaler that administers a solution with a nominal dose per actuation of 87 μg, 5 μg, and 9 μg of the active substances, respectively.

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

Both medicines are indicated for the maintenance treatment of adults with moderate to severe COPD who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta-2 agonist.

The applications for CHF 5993 and Trydonis were informed consent applications, which make use of data from the dossier of a previously authorized medicine. The reference product for CHF 5993 and Trydonis is Trimbow, also from Chiesi Farmaceutici SpA.

The summary of product characteristics will provide detailed recommendations for the use of these products. It will be published in all official EU languages in the European public assessment report after the European Commission grants marketing authorization.

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