AstraZeneca announced disappointing top-line results from the AERISTO Phase IIIb trial for the Bevespi Aerosphere in patients with moderate to very severe chronic obstructive pulmonary disease (COPD).
The inhaled drug did not perform better than a similar drug.
Dr Colin Reisner, head of Respiratory, Global Medicines Development, said: “The efficacy and safety of Bevespi Aerosphere has been established by the Phase III PINNACLE trial program involving more than 5,000 patients. The performance of Bevespi Aerosphere in AERISTO is inconsistent with previous data. A full analysis is underway to understand and characterize these findings and will be presented at a forthcoming medical meeting.”
Bevespi Aerosphere is approved in the US and Canada for the long-term maintenance treatment of airflow obstruction in COPD. Bevespi Aerosphere is currently under review by the European Medicines Agency with a regulatory decision anticipated in the second half of this year.
COPD is a progressive disease which can cause obstruction of airflow in the lungs resulting in bouts of breathlessness.1 It affects an estimated 384 million people worldwide and is predicted to be the third leading cause of death by 2020. The condition is often tied to smoking.
About one-third of COPD patients have severe or very severe forms of the disease. Improving lung function, reducing exacerbations and managing daily symptoms such as breathlessness are important to the management of COPD.
Lung disease is one of the areas of focus for AstraZeneca as it works to build a drug development pipeline.
AstraZeneca has 1,500 employees and its U.S. headquarters near Wilmington.
