December 14, 2020: “AstraZeneca’s Trixeo Aerosphere (formoterol fumarate/glycopyrronium bromide/budesonide) has been approved in the EU for 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 (ICS) and a long-acting beta2-agonist (LABA), or a combination of a LABA and a long-acting muscarinic antagonist (LAMA).
The approval by the European Commission was based on positive results from the ETHOS Phase III trial in which Trixeo Aerosphere, a triple-combination therapy, showed a statistically significant reduction in the rate of moderate or severe exacerbations compared with dual-combination therapies Bevespi Aerosphere (glycopyrronium/formoterol fumarate) and PT009 (budesonide/formoterol fumarate) over 52 weeks.
The approval was also supported by efficacy and safety data from the KRONOS Phase III trial.
Trixeo Aerosphere was recommended for marketing authorisation by the Committee for Medicinal Products for Human Use of the European Medicines Agency in October 2020.
COPD is a progressive disease, which can cause obstruction of airflow in the lungs resulting in debilitating bouts of breathlessness and is the third leading cause of death globally.3-6
Klaus Rabe, Professor of Pulmonary Medicine at the University of Kiel, Director of the Department of Pneumology at Clinic Grosshansdorf, Germany, and lead investigator of the ETHOS Phase III trial, said: “Chronic obstructive pulmonary disease significantly contributes to morbidity and healthcare resource utilisation in Europe.
Even a single exacerbation can cause further deterioration of a patient’s lung function and increase the risk of hospitalisation, so preventing exacerbations is a clinical priority.
Trixeo Aerosphere has demonstrated significant benefits in reducing exacerbations in patients with moderate to severe disease, and triple-combination therapy will play an increasingly important clinical role in treating these patients.”
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “Trixeo Aerosphere has a strong clinical profile compared with dual-combination therapies and offers an important new treatment option for patients with chronic obstructive pulmonary disease.
In Europe, about one in 10 adults over the age of 40 has chronic obstructive pulmonary disease, with prevalence increasing. We look forward to discussing all-cause mortality data from the ETHOS Phase III trial with health authorities.”
Results from the ETHOS Phase III trial were published in The New England Journal of Medicinein June 2020 and results from the KRONOS Phase III trial were published in The Lancet Respiratory Medicine in September 2018.
In both trials, the safety and tolerability of Trixeo Aerosphere were consistent with the profiles of the dual comparators.
COPD
COPD is a progressive disease which can cause obstruction of airflow in the lungs resulting in debilitating bouts of breathlessness.
It affects an estimated 384 million people and is the third leading cause of death globally.
In Europe, approximately 10% of adults over the age of 40 have COPD, with prevalence set to increase, significantly contributing to morbidity and healthcare resource utilisation.
Improving lung function, reducing exacerbations and managing daily symptoms such as breathlessness are important treatment goals in the management of COPD.
A single COPD exacerbation can have a negative impact on lung function, quality of life and increase the risk of hospitalisation.
Additionally, even one COPD exacerbation that results in hospitalisation increases the risk of death.
ATHENA clinical trial programme
The ETHOS and KRONOS Phase III trials are part of AstraZeneca’s ATHENA Phase III clinical trial programme for Trixeo Aerosphere, which included more than 15,500 patients globally across 11 trials.
ETHOS is a randomised, double-blinded, multi-centre, parallel-group, 52-week Phase III trial to assess the efficacy and safety of Trixeo Aerosphere in symptomatic patients with moderate to very severe COPD and a history of exacerbation(s) in the previous year.
The primary endpoint was the rate of moderate or severe exacerbations. Results were published in The New England Journal of Medicine.
KRONOS is a randomised, double-blinded, parallel-group, 24-week, chronic-dosing, multi-centre Phase III trial to assess the efficacy and safety of Trixeo Aerosphere in patients with moderate to very severe COPD regardless of whether or not they had an exacerbation in the previous year.
The primary endpoints were lung function parameters. Results were published in The Lancet Respiratory Medicine.
Trixeo Aerosphere
Trixeo Aerosphere (formoterol fumarate/glycopyrronium bromide/budesonide) is a single-inhaler, fixed-dose triple-combination of formoterol fumarate, a LABA, glycopyrronium bromide, a LAMA, with budesonide, an ICS, and delivered in a pressurised metered-dose inhaler.”
Trixeo Aerosphere is approved under the brand name Breztri Aerosphere in Japan, China and the US for patients with COPD.”
https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2020/trixeo-aerosphere-approved-in-the-eu-for-copd.html
