EU nod for Chiesi’s COPD therapy

The treatment is targeted towards patients who are not adequately treated by a combination of an inhaled corticosteroid (ICS) and a long-acting beta2-agonist (LABA).

Trimbow is the first three-in-one combination inhaler containing an ICS (beclometasone dipropionate), a LABA (formoterol fumarate, FF) and a long-acting muscarinic antagonist (LAMA, glycopyrronium bromide), administered as a twice-daily fixed-dose in a pressurised metered-dose inhaler extrafine formulation.

Its approval is based in part on data from the Phase III Trilogy study, which showed the triple combination is superior to the fixed dose ICS/LABA combined therapy on a number of clinical efficacy parameters, including morning pulmonary function prior to the intake of the first daily dose and FEV1 (Forced Expiratory Volume in 1 second).

After 52 weeks' treatment, the annual rate of moderate and severe COPD exacerbations was reduced by 23 percent, which the firm previously highlighted as "extremely important" given that exacerbations worsen the quality of life of a COPD patient more than any factor, often leading to hospital admission and representing the main cause of death in patients.

"The marketing authorisation of Trimbow in the EU is a significant treatment advance for COPD patients and reinforces the Chiesi Group’s leadership in the respiratory arena," noted Alessandro Chiesi, Region Europe head, Chiesi Group.

"Trimbow is the first approved fixed triple combination therapy in a single inhaler for the treatment of COPD. The use of one inhaler should simplify the intake of the therapy and therefore may improve adherence. We aim to make this treatment available to patients in Europe as soon as possible."

In the UK, the National Institute for Health and Care Excellence currently recommends triple therapy (the combination of an ICS/LABA and LAMA in two separate inhalers) in "patients who remain breathless or have exacerbations despite taking ICS/LABA, irrespective of FEV1".