AstraZeneca gets approval for COPD treatment in US
AstraZeneca announced on Friday that ‘Breztri Aerosphere’, or budesonide, glycopyrrolate and formoterol fumarate, has been approved in the United States for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
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The FTSE 100 pharmaceuticals giant said the approval by the Food and Drug Administration (FDA) was based on positive results from the phase 3 ‘ETHOS’ trial, in which the triple-combination therapy showed a statistically significant reduction in the rate of moderate or severe exacerbations, compared with dual-combination therapies ‘Bevespi Aerosphere’, or glycopyrrolate and formoterol fumarate, and ‘PT009’, or budesonide and formoterol fumarate.
It said the approval was also supported by efficacy and safety data from the phase 3 ‘KRONOS’ trial.
“Preventing exacerbations is central to the management of chronic obstructive pulmonary disease,” said Dr Fernando Martinez, chief of pulmonary and critical care medicine at Weill Cornell Medicine and New York-Presbyterian Weill Cornell Medical Center, and investigator in the ‘ETHOS’ trial.
“Even a single exacerbation can have a negative impact on a patient's lung function and quality of life, and it can increase the risk of death.
“Breztri Aerosphere has demonstrated significant benefits in reducing exacerbations in patients suffering from COPD.”
Results from the phase 3 ‘ETHOS’ trial were published in the New England Journal of Medicine in June, and results from the phase 3 ‘KRONOS’ trial were published in The Lancet Respiratory Medicine in September 2018.
AstraZeneca said that in both trials, the safety and tolerability of Breztri Aerosphere was consistent with the profiles of the dual comparators.
“Breztri Aerosphere has demonstrated a strong clinical profile compared with dual-combination therapies and offers a meaningful new treatment option for patients,” said Mene Pangalos, executive vice-president of biopharmaceuticals research and development at AstraZeneca.
“Chronic obstructive pulmonary disease is a debilitating progressive condition and the fourth leading cause of death in the US.
“We look forward to discussing all-cause mortality data from the Breztri Aerosphere ETHOS trial with health authorities.”
AstraZeneca said Breztri Aerosphere was not indicated for the relief of acute bronchospasm or for the treatment of asthma in the US or other countries.
It has been approved in Japan and China for patients with COPD, and remained under regulatory review in the European Union.