AstraZeneca's Breztri Aerosphere Approved by US FDA and Already Launched in China for COPD Maintenance Treatment

July 25, 2020 News /BioValleyBIOON/ --AstraZeneca(AstraZeneca) recently announced that the U.S. Food and Drug Administration (FDA) has approved the triple therapy Breztri Aerosphere (Chinese brand name: Beize Rui® Ling Chang®, budesonide/glycopyrronium/formoterol fumarate, Bude Ge Fu inhalation aerosol) for maintenance treatment in patients with chronic obstructive pulmonary disease (COPD).

Previously, Breztri Aerosphere (Breztri® Aerosphere®, budesonide/glycopyrronium/formoterol fumarate inhalation aerosol) was approved for marketing in Japan and China in June and December 2019, respectively, for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Currently, the drug is undergoing regulatory review in Europe. Breztri Aerosphere is a fixed-dose triple-combination inhalation formulation, delivered via the innovative Aerosphere® device and utilizing novel co-suspension delivery technology to jointly administer three active ingredients: budesonide (an inhaled corticosteroid, ICS), glycopyrronium (a long-acting muscarinic antagonist, LAMA), and formoterol fumarate (a long-acting beta2-agonist, LABA). It provides an important therapeutic option for patients with stable COPD.

This timeFDAApproved, 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 to two dual therapies: Bevespi Aerosphere (glycopyrrolate/formoterol fumarate) and PT009 (budesonide/formoterol fumarate). Key secondary endpoint data indicated that, compared to Bevespi Aerosphere, Breztri Aerosphere reduced the risk of all-cause mortality by 46% (uncorrected p = 0.01). In this trial, the two dual therapies used as controls represent the currently recommended treatment categories for COPD.

Furthermore, thisFDAThe approval was also 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 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 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 over 40 being a COPD patient. 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 damage to lung function, 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 the first acute exacerbation. (Bioon.com)

Original source:Breztri Aerosphere approved in the US for the maintenance treatment of COPD