AstraZeneca’s fixed-dose triple-combination Trixeo Aerosphere (budesonide/glycopyrronium/formoterol fumarate dihydrate or BGF) has been approved in the European Union (EU) as a maintenance treatment for asthma. 

It is approved in patients 12 years of age and older who are not adequately controlled by a combination of a medium dose inhaled corticosteroid (ICS) and long-acting beta2-agonist (LABA).  

Trixeo Aerosphere, marketed as Breztri Aerosphere in the US, China and Japan, is a single inhaler that combines ICS/LABA with a long-acting muscarinic antagonist (LAMA). 

The approval by the European Commission (EC) follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and was based on the positive results from the KALOS and LOGOS Phase III trials.  

In the trials, Trixeo demonstrated statistically significant improvements in lung function compared with combined ICS/LABA comparators. In the pooled analysis of KALOS and LOGOS, Trixeo demonstrated a statistically significant reduction in the annualised rate of severe asthma exacerbations versus combined ICS/LABA comparators in a broad population of patients including those with no asthma exacerbations in the previous year. 

Alberto Papi, Professor and Chair of Respiratory Medicine at the University of Ferrara, and Director of the Respiratory Unit, CardioRespiratory Department, S Anna University Hospital, Ferrara, Italy, and primary investigator, said: “The approval of Trixeo in Europe as the first triple-combination therapy in a single inhaler for patients 12 years of age and older provides an important new treatment option that has been shown to improve asthma control and reduce future risk of exacerbations, regardless of exacerbation history.” 

Trixeo/Breztri is also approved in the US and Japan for treatment of asthma and is currently under review in China and other countries. It is also approved for the treatment of COPD in adults in 90 countries worldwide.