Chiesi cleared to market COPD drug in Europe

The European Commission has granted the marketing authorization for Trimbow (beclomethasone dipropionate/formoterol fumarate dihydrate/glycopyrronium) for the 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 (for effects on symptoms control and prevention of exacerbations).

As a result, Trimbow, from Italian family-owned drugmaker Chiesi Group, is now approved for use in the 31 European countries covered by the European Medicines Agency (EMA).

Trimbow is the first three-in-1 combination inhaler containing an inhaled corticosteroid (ICS) / long-acting β2-agonist (LABA) / long-acting muscarinic antagonist (LAMA) containing beclomethasone dipropionate (BDP; 87mcg), formoterol fumarate (FF, 5mcg) and glycopyrronium (GB, 9mcg), administered as a twice-daily fixed-dose in a pressurised metered-dose inhaler (pMDI) extrafine formulation.