The European Commission (EC) has approved a marketing authorisation for Chiesi Group’s triple combination asthma therapy Trimbow (beclometasone/formoterol/glycopyrronium).
The marketing authorisation indicates Trimbow for use as a maintenance treatment for adult asthma patients, whose condition is not adequately controlled with a combination of long-acting beta2-agonist (LABA) and medium dose of inhaled corticosteroid (ICS).
Patients must have also experienced one or more asthma exacerbations in the previous year.
Chiesi’s triple asthma therapy has been shown to reduce exacerbations and improve lung function in patients with uncontrolled asthma, compared to ICS/LABA.
Both the CHMP’s recommendation and the EC’s approval are based on efficacy and safety data from four clinical studies, involving almost 3,000 patients.
“This is the first step towards taking our triple therapy for moderate to severe COPD patients and providing the same treatment option for appropriate asthma patients,” said Alessandro Chiesi, chief commercial officer of Chiesi Group.
“The European Commission’ approval brings us one step closer to providing uncontrolled adult asthma patients with a new treatment option for their care, reducing exacerbations and potentially simplifying the use for patients, thanks to a single inhaler triple therapy,” he added.
According to the Global Initiative for Asthma (GINA), people living with uncontrolled asthma have poor symptom control and can also experience frequent exacerbations that require oral corticosteroids.
These patients can also experience serious exacerbations that require hospitalisation.