Slow-blocking lung innovation! AstraZeneca triple-Butigfo inhalation aerosol (pepper-sage ® Chang ®) Phase III clinical efficacy is strong, China has been listed!
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Last Update: 2020-07-19
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Source: Internet
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Author: User
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, 25 June 2020/
BIOON/
Astra
Zeneca announces the results of the Triple Treatment Breztri Aerosphere (Chinese Product Name: Penadere ® Chang ®, Budinaid/Grun Bromine/Fumasaufomotro, Budigfoinaero aerosol) III ETHOS testThe data showed that breztri Aerosphere showed a statistically significant reduction in moderate to severe acute exacerbation rates in patients with moderate to severe chronic obstructive pulmonary disease (COPD, COPD, COPD) compared to two combination therapiesBreztri Aerosphere (Pepperey ®,®, Budigefu Inhalant Aerosol) has been approved for use in China and Japan for the maintenance of patients with COPDThe drug is currently subject to regulatory approval in the United States and EuropeBudigefu inhalation aerosols use innovative co-suspension administration technology to jointly deliver three drug components: budinide (inhalation of glucocorticoidIC ICS) / Grun bromide (long-acting anticholinergic drug LAMA) / Fumaacid fomotero (long-acting beta 2 receptor agonists LABA), providing an important therapeutic option for patients with chronic lung resistance during the stable periodreleased data this time, Breztri Aerosphere significantly reduced the acute exacerbation rate by 24% (p 0.001) compared to Bevespi AerosphereBreztri Aerosphere significantly reduced the acute exacerbation rate by 13% compared to PT009 (Boudine/Fumasinfomotro) (p-0.003)In this trial, the two bi-binary therapies used as controls represent the current recommended treatment category for COPD (Note: PT009 is not available worldwide and has not yet been used for COPD)at a critical secondary endpoint, Breztri Aerosphere showed a 46% reduction in the risk of all-cause death compared to Bevespi Aerosphere (Grun Bromo/Fomotero) (uncorrected p-0.01)click on the image to see the large picture (picture source: NEJM)The safety and tolerance of Breztri Aerosphere is consistent with the known properties of 2 bi-combination therapiesThe most commonly reported adverse events in this trial were nasopharyngitis, COPD and upper respiratory tract infectionsIn the Breztri Aerosphere group, the diagnosis rate for pneumonia was 4.2%, in the Bevespi Aerosphere group was 2.3% and in the PT009 group it was 4.5%these results are based on Breztri Aerosphere (Budined/Grun Bromboama/Fumaacid Fomotro, 320/14.4/9.6mcg) using a standard dose of budined (an inhaled glucocorticoid, ICS)In this trial, Breztri Aerosphere (Budinaid/Grun Bromon ammonium/Fuma acid fomotro, 160/14.4/9.6mcg) was used in half doses of Budinaid, with Bevespi Aerosphere (Grun) Brominated ammonium/Fomotero, 14.4/9.6mcg and PT009 (Budinide/Fumasinfomotro, 320/9.6mcg) also showed a statistically significant reduction in moderate to severe aggravation rates the results have been published in the New England Journal of Medicine (NEJM), the world's leading medical journal, and published at the American Thoracic Society 's Virtual Science Symposium's Clinical Trials of Lung
Medicine Clinical Trials AstraZeneca will continue to review the data with health regulators "The results of the Phase III ETHOS trial are important and demonstrate the benefits of Brez Aerotrisphere in reducing the rate of exacerbation of this progressive disease," said Klaus Rabe, lead researcher on the ETHOS trial at the and professor of pulmonary medicine at the University of Kiel in Germany and director of the respiratory department at the Grossansdorf Clinic in Germany The results also suggest that reducing the risk of all-cause mortality is achievable and may be a possible target for the treatment of chronic obstructive pulmonary disease "Chronic obstructive pulmonary disease is the third leading cause of death in the world, and increased disease may lead to increased patient mortality," said Mene Pangalos, executive vice president of research and development at auslemost AstraZeneca Biopharmaceuticals in The results of the Stage III ETHOS trial support the strong clinical characteristics of Breztri Aerosphere in reducing the exacerbation rate compared to biptotherapy We are excited about the data on total mortality, which is a key consideration in the management of chronic obstructive pulmonary disease "
Breztri Aerosphere (Pepperey® Chang ®, Budinaid/Grun Bromaminamin/Fuma acid fomotro, Budigfo inhalation aerosols) is a fixed-dose three-in-one inhalation agent, using innovative and innovative devices to jointly deliver Budinaid Three pharmaceutical components (inhalation of glucocorticoidICic acid ICS) / Grun bromide (long-acting anticholinergic drug LAMA) / Fumaacid Fomotro (long-acting beta 2 receptor agonisant LABA) provide important treatment options for suitable COPD patients and provide patients with convenient and innovative drug administration Budigefu inhaler is equipped with an innovative ling device for the application of a total suspension drug technology This technological innovation enables the drug to reach the lung-sized airways and achieves a high lung deposition rate At the same time, the dose of each spray is stable, so that the first to the last inhalation, can be delivered the correct dose in China, Budigefu inhale aerosols were eligible for priority review in January 2019 and approved by the State Drug Administration (NMPA) in December 2019 for maintenance treatment for patients with COPD As an innovative triple inhalation drug for COPD therapy, Budigof inhaled aerosols were approved in Europe and the United States, making China the second country in the world to approve the drug In June, the drug was first introduced in Japan under the brand name Breztri Aerosphere (PT010) as a triple therapy to relieve copD symptoms slow-blocking lung is one of the most common chronic respiratory diseases in China The latest flow data for 2018 show that the total number of PATIENTs with COPD in China is nearly 100 million, with an average of one in seven 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 number of moderate acute exacerbations in patients with COPD in China is as high as 3 times a year Acute exacerbation can lead to rapid progression of the disease, resulting in irreversible damage to lung function and greatly increasing the risk of death Data show that after the first acute aggravation discharge, the 3.6-year all-cause mortality rate climbed to 50%, 7.7 years as high as 75% compared to duplysing drugs, Budigof inhalation triple therapy offers multiple benefits for patients with COPD The KRONOS study, published in the Lancet Respiratory Medicine, showed that the bourdinide/Grun brominated ammonium/Fumaacid fomotro triple therapy significantly reduced the moderate to severe exacerbation rate by 52% and prolonged the time to reach the first moderate to severe acute exacerbation compared to the double bronchodilator therapy At the same time, the drug is effective quickly and sustainably significantly improves lung function in patients, and has good safety (BioValleyBioon.com) original source: Breztri Aerospherely reduced rate of moderate or COPD severed bigdions in Phase III ETHOS trial .
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