24th Jul 2020 09:26
(Alliance News) - AstraZeneca PLC on Friday said Breztri Aerosphere has been approved by the US Food & Drug Administration for the maintenance treatment of patients with chronic obstructive pulmonary disease.
COPD is a progressive disease which can cause obstruction of airflow in the lungs resulting in debilitating bouts of breathlessness.
Breztri Aerosphere is a combination of budesonide, glycopyrronium, and formoterol fumarate.
The FTSE 100 drug manufacturer said the approval by the regulatory body was based on positive results from the phase 3 ETHOS trial in which the drug showed a statistically significant reduction in the rate of moderate or severe exacerbations when compared with dual-combination therapies Bevespi Aerosphere - a combination of glycopyrrolate and formoterol fumarate - and PT009 which is a combination of budesonide and formoterol fumarate.
"Preventing exacerbations is central to the management of chronic obstructive pulmonary disease. 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," said Fernando Martinez, chief of division of Pulmonary & Critical Care Medicine at Weill Cornell Medicine and investigator in the ETHOS trial.
AstraZeneca shares were trading 2.7% lower at 8,511.80 pence each on Friday morning in London.
By Ife Taiwo; [email protected]
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