European Union Approves Chiesi’s COPD Maintenance Therapy Trimbow

The European Union has approved Trimbow as a maintenance treatment for adults with moderate to severe chronic obstructive pulmonary disease.

Trimbow, developed by Italy’s Chiesi Group, is the first triple-combination inhaler for COPD. It contains the inhaled corticosteroid beclometasone dipropionate, the β2 agonist formoterol fumarate, and the muscarinic antagonist glycopyrronium.

A corticosteroid is a medicine used to treat allergies, inflammation and itching. An agonist binds to receptor, prompting the receptor to produce a biological response. An antagonist prevents a receptor from acting.

Trimbow is for people with COPD who fail to respond to a combination of an inhaled corticosteroid and a β2 agonist.

Britain’s National Institute for Health and Care Excellence recommends a triple therapy for patients who remain breathless or experience COPD exacerbations after taking a double therapy.

In addition, an important COPD report says a triple inhaled therapy does a better job than a double at improving patients’ lung function, symptoms and overall health and reducing their exacerbations. The Global Initiative for Chronic Obstructive Lung Disease generated the report, popularly known as the GOLD report.

“The marketing authorization of Trimbow in the EU is a significant treatment advance for COPD patients and reinforces the Chiesi Group’s leadership in the respiratory arena,” Alessandro Chiesi, who heads the group’s European operation, said in a press release.

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

Chiesi has evaluated Trimbow in 12 clinical trials covering 7,000 patients. It recently published the results of two trials in The Lancet.

One showed that Trimbow outperformed a double combo on a number of COPD measurements, including exacerbations, and its safety profile was comparable to the double’s. The study was titled “Single inhaler triple therapy versus inhaled corticosteroid plus long-acting β2-agonist therapy for chronic obstructive pulmonary disease (TRILOGY): a double-blind, parallel group, randomised controlled trial,”

The other trial demonstrated that Trimbow did a better job of treating COPD than the β2 agonist tiotropium. The study was titled “Single inhaler extrafine triple therapy versus long-acting muscarinic antagonist therapy for chronic obstructive pulmonary disease (TRINITY): a double-blind, parallel group, randomised controlled trial,”