Slow-blocking pulmonary triple therapy! AstraZeneca Breztri Aerosphere (Budigeford) has been approved by the U.S. FDA and is listed in China!

July 25, 2020 // AstraZeneca recently announced that the U.S. Food and Drug Administration (FDA) has approved the maintenance of the treatment of triple therapy Breztri Aerosphere (Chinese product name: Pirelli ®®, Budinaide/Grun bromine/Fumasaufomotro, Budigeford chronic obstructive pulmonary disease (COPD) patients. Prior to
, Breztri Aerosphere (Pepper® Chang ®, Budigfo Inhaled Aerosol) was approved for the market in Japan and China in June 2019 and December 2019 for the maintenance of COPD patients.
the drug is currently being approved by regulators in Europe.
Breztri Aerosphere is a fixed-dose three-in-one inhalation agent equipped with an innovative lactation device, the application of innovative co-suspended drug technology, the joint delivery of budinide (inhalation of glucocorticoidIC ICS) / gron bromon bromide (long-acting anticholinergic drug LAMA) / Fumaacid Fomotro (long-acting beta 2 receptor agonisant LABA) three drug components, providing an important treatment for patients with stable duration of pulmonary obstruction.
FDA approval based on positive results from Phase III ETHOS tests.
data show that in patients with moderate to severe chronic obstructive pulmonary disease (COPD, COPD, COPD), with 2 duped therapy Bevespi Aerosphere (Grun brommyamin/Fumaawmodoro) and PT009 Breztri Aerosphere statistically significantly reduced the moderate to severe acute exacerbation rates by 24% (p.001) and 13% (p-0.003) (bourdnydd/Fumasinfomotro) respectively.
key secondary endpoint data show that Breztri Aerosphere reduced the risk of death by 46% compared to Bevespi Aerosphere (uncorrected p-0.01).
the two bi-binary therapies used as controls represent the current recommended treatment categories of COPD.
, the FDA approval is also supported by the validity and safety data of The KroNOS trial of Phase III.
the study showed that Breztri Aerosphere significantly reduced the moderate to severe acute exacerbation rate by 52% and delayed the first moderate to severe acute exacerbation compared to double bronchodilator therapy.
at the same time, the drug is effective quickly and sustainably significantly improves lung function in patients, with good safety. 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, breztri Aerosphere's safety and tolerance were consistent with the characteristics of biptotherapy.
in China, Breztri Aerosphere (Budigevo inhaling aerosols) was qualified for priority review in January 2019 and officially approved by the National Drug Administration (NMPA) in December 2019 for maintenance treatment for patients with COPD.
as an innovative triple-inhalation drug for COPD therapy, Budigfo inhaled aerosols were approved earlier than in Europe and the United States, making China the second country in the world after Japan to approve the drug.
slow-blocking lung is one of the most common chronic respiratory diseases in China.
the latest flow data for 2018, the total number of COPD patients in China is nearly 100 million, with an average of one in 7 people over the age of 40.
patients with COPD often appear due to the sudden increase of symptoms leading to hospital visits or even hospitalization, that is, acute exacerbation of COPD. according to statistics
, the median acute exacerbation of patients in China's chronic ally pulmonary care is up to 3 times a year.
acute exacerbation can lead to rapid progression of the disease, resulting in irreversible damage to lung function, and greatly increase the risk of death.
data show that after the first acute aggravation discharge, the overall cause mortality rate climbed to 50 per cent in 3.6 years and 75 per cent in 7.7 years.
() Original origin: Breztri Aerosphere approved in the US for the maintenance treatment of COPD.