-
Categories
-
Pharmaceutical Intermediates
-
Active Pharmaceutical Ingredients
-
Food Additives
- Industrial Coatings
- Agrochemicals
- Dyes and Pigments
- Surfactant
- Flavors and Fragrances
- Chemical Reagents
- Catalyst and Auxiliary
- Natural Products
- Inorganic Chemistry
-
Organic Chemistry
-
Biochemical Engineering
- Analytical Chemistry
-
Cosmetic Ingredient
- Water Treatment Chemical
-
Pharmaceutical Intermediates
Promotion
ECHEMI Mall
Wholesale
Weekly Price
Exhibition
News
-
Trade Service
December 15, 2020 // -- AstraZeneca recently announced that the European Commission (EC) has approved Trixeo Aerosphere (Chinese commodity names®: Peregrine® Fog agents) for maintenance therapy in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD), specifically in patients who receive a combination of an inhaled corticosteroid (ICS) and a long-acting beta-2-receiving atrial atrium (LABA), or a combination of LABA and a long-acting venom-alkali antagonist (LAMA) that does not adequately control the condition.
Trixeo Aerosphere is a triple therapy that has previously been approved in Japan, China and the United States and is available under the brand name Breztri Aerosphere for maintenance therapy for COPD patients.
Trixeo Aerosphere is a fixed-dose, three-in-one inhalation agent equipped with an innovative device that uses innovative co-suspended carrier technology to jointly deliver Budinade (inhaled glucoticoid ICS)/Glon bromide (long-acting anticholinel energy drug LAMA)/Fuma acid Fumotro (long-acting beta-2-acting atrial astigturist LABA) three drug components to provide an important treatment option for patients with a stable period of chronic retardant.
this approval, based on the positive results of the Phase III ETHOS test.
data show that in patients with moderate to severe chronic obstructive pulmonary disease (COPD, COPD), bevespi Aerosphere (Grombromum/Fumaric acid Fomotro) and PT009 (Budined) are associated with two combination therapies Trixeo Aerosphere statistically reduced moderate to severe acute exacerbation rates by 24% (p<0.001) and 13% (p.003), respectively, compared to Fumaric Acid Fomotro.
key secondary endpoint data show that Trixeo Aerosphere reduces the risk of all-cause death by 46% compared to Bevespi Aerosphere (unresolted p-0.01).
trial, the two combination therapies used as a control represent the current recommended treatment category for COPD.
addition, this approval is supported by validity and security data for Phase III KRONOS trials.
study showed that Trixeo Aerosphere significantly reduced moderate to severe acute exacerbation rates by 52% compared to the treatment of double bronchid dilates, and delayed the occurrence of the first moderate to severe acute exacerbation.
, the drug is fast and sustainable, significantly improving lung function and providing good safety.
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, Trixeo Aerosphere's safety and tolerance were consistent with the characteristics of the twin therapy.
in China, Breztri Aerosphere (Budigford Inhaled Aerosol) was eligible for priority review in January 2019 and was officially approved by the National Drug Administration (NMPA) in December 2019 for maintenance treatment for patients with COPD.
as a triple inhalation innovative drug for slow-blocking lung therapy, Budigford inhalation aerosols were approved earlier than in Europe and the United States, making China the second country in the world to approve the drug after Japan.
is one of the most common chronic respiratory diseases in China.
the latest flow data for 2018, the total number of chronic lung patients in China is nearly 100 million, with an average of one in seven people over the age of 40.
patients with chronic obstructive pulmonary disease often appear because of the sudden aggravation of symptoms leading to hospital visits or even hospitalization, that is, acute exacerbation of PHOSD lung.
statistics, the number of medium acute exacerbations per year for patients with chronic pulmonary obstruction in China is as high as 3 times.
can lead to rapid progression of the disease, cause irreversible damage to lung function, and greatly increase the risk of death in patients.
data show that after patients were discharged from hospital with the first acute exacerbation, the total cause mortality rate climbed to 50% in 3.6 years and as high as 75% in 7.7 years.
() original source: Trixeo Aerosphere approved in the EU for maintenance treatment of COPD14 December 2020