AstraZeneca's Trixeo Aerosphere Receives Positive CHMP Opinion for COPD Maintenance Treatment in the EU

AstraZeneca recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending approval of Trixeo Aerosphere (Chinese brand name: Beize Rui), which has already been approved by the U.S. Food and Drug Administration (FDA).^®Lingchang^®, budesonide/glycopyrronium/formoterol fumarate, Breztri Aerosphere), for maintenance treatment in patients with chronic obstructive pulmonary disease (COPD).

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

Breztri 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).

The CHMP’s positive opinion 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), Breztri Aerosphere significantly reduced the rate of moderate-to-severe exacerbations by 24% (p < 0.001) and 13% (p = 0.003), respectively, compared with the two dual therapies Bevespi Aerosphere (glycopyrronium/formoterol fumarate) and PT009 (budesonide/formoterol fumarate). Key secondary endpoint data indicated that Breztri Aerosphere reduced the risk of all-cause mortality by 46% compared with 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 CHMP’s positive opinion was supported by efficacy and safety data from the Phase III KRONOS trial. The study demonstrated that, compared with dual bronchodilator therapy, Breztri 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 demonstrated 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 Breztri Aerosphere was consistent with that of dual therapy.

In China, Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate dihydrate inhalation aerosol) was granted priority review status in January 2019 and officially approved by the National Medical Products Administration (NMPA) in December 2019 for maintenance treatment in 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 show that the total number of COPD patients in China is nearly 100 million, with one in every seven people aged 40 and older affected by the disease. Patients with COPD frequently experience sudden worsening of symptoms, leading to hospital visits or even hospitalization, known as acute exacerbations of COPD (AECOPD). Statistics indicate that the median number of acute exacerbations per year among COPD patients seeking medical care in China is as high as three. Acute exacerbations can lead to rapid disease progression, cause irreversible lung function impairment, and significantly increase the risk of mortality. Data show that the all-cause mortality rate rises to 50% within 3.6 years and reaches 75% within 7.7 years after discharge following a patient’s first acute exacerbation.

Original Source: Trixeo Aerosphere Recommended for Approval in the EU by CHMP for the Maintenance Treatment of COPD

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