AstraZeneca's Trixeo Aerosphere (Budesonide/Glycopyrronium/Formoterol) Approved in the EU for COPD Maintenance Treatment; Already Launched in China

December 15, 2020 /Bio ValleyBIOON/ --AstraZeneca(AstraZeneca) recently announced that the European Commission (EC) has approved Trixeo Aerosphere (Chinese brand name: Breztri® Aerosphere®, budesonide/glycopyrronium/formoterol fumarate, budesonide/glycopyrronium/formoterol fumarate pressurized metered-dose inhaler) for maintenance treatment in adult patients with moderate-to-severe chronic obstructive pulmonary disease (COPD), specifically those whose disease is not adequately controlled with a combination of an inhaled corticosteroid (ICS) and a long-acting beta2-agonist (LABA), or with a combination of a LABA and a long-acting muscarinic antagonist (LAMA).

Trixeo Aerosphere is a triple therapy that has previously been approved in Japan, China, and the United States, marketed under the brand name Breztri Aerosphere for maintenance treatment in patients with COPD.

Trixeo Aerosphere is a fixed-dose triple-combination inhalation formulation, delivered via the innovative Breezhaler device and utilizing novel co-suspension drug delivery technology to jointly administer budesonide (an inhaled corticosteroid, ICS), glycopyrronium bromide (a long-acting muscarinic antagonist, LAMA), and formoterol fumarate (a long-acting β2-agonist, LABA). It provides an important therapeutic option for patients with stable chronic obstructive pulmonary disease (COPD).

This approval is based on the positive results from the Phase III ETHOS trial. The data showed that, in patients with moderate to very severe chronic obstructive pulmonary disease (COPD), Trixeo Aerosphere significantly reduced the rate of moderate-to-severe exacerbations by 24% (p < 0.001) and 13% (p = 0.003), respectively, compared to two dual therapies: Bevespi Aerosphere (glycopyrrolate/formoterol fumarate) and PT009 (budesonide/formoterol fumarate). Key secondary endpoint data indicated that Trixeo Aerosphere reduced the risk of all-cause mortality by 46% compared to Bevespi Aerosphere (unadjusted p = 0.01). In this trial, the two dual therapies used as comparators represent the currently recommended treatment classes for COPD.

Furthermore, the approval was supported by efficacy and safety data from the Phase III KRONOS trial. The study demonstrated that, compared with dual bronchodilator therapy, Trixeo Aerosphere significantly reduced the rate of moderate-to-severe exacerbations by 52% and delayed the time to first moderate-to-severe exacerbation. Meanwhile, the drug exhibited a rapid onset of action, sustained significant improvements in lung function, and a favorable safety profile.

The results of the ETHOS trial were published in The New England Journal of Medicine in June 2020, and the results of the KRONOS trial were published in The Lancet Respiratory Medicine in September 2018. In both trials, the safety and tolerability profile of Trixeo Aerosphere was consistent with that of dual therapy.

In China, Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate inhalation aerosol) was granted priority review status in January 2019 and received formal approval from the National Medical Products Administration (NMPA) in December 2019 for maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). As an innovative triple-combination inhaled therapy for COPD, Breztri Aerosphere was approved in China prior to its approval in Europe and the United States, making China the second country globally, after Japan, to approve this medication.

Chronic obstructive pulmonary disease (COPD) is one of the most common chronic respiratory diseases in China. The latest epidemiological survey data from 2018 shows that the total number of COPD patients in China is nearly 100 million, with one in every seven people over the age of 40 affected by COPD. Patients with COPD often experience sudden worsening of symptoms, leading to hospital visits or even hospitalization, known as acute exacerbations of COPD. According to statistics, the median number of acute exacerbations per year among COPD patients in China is as high as three times. Acute exacerbations can lead to rapid progression of the disease, causing irreversible damage to lung function and significantly increasing the risk of death for patients. Data shows that within 3.6 years after discharge following a patient's first acute exacerbation, the all-cause mortality rate rises to 50%, reaching 75% at 7.7 years. (Bioon.com)

Original Source: Trixeo Aerosphereapproved in the EU for maintenance treatment of COPD

14 December 2020