Positive top-line results for AstraZeneca's new COPD dual therapy

The UK’s AstraZeneca has announced top-line results of the Phase III PINNACLE 4 trial, comparing dual therapy Bevespi Aerosphere (glycopyrronium and formoterol fumarate) with its monotherapy components and with placebo.

The company says the data show a statistically significant improvement in lung function in patients with moderate to very severe chronic obstructive pulmonary disease (COPD).

The data will be used to support regulatory filings in Japan and China next year.

Bevespi Aerosphere is approved in the USA for the long-term maintenance treatment of airflow obstruction in COPD.

The EMA is expected to rule on a regulatory application in this indication in the second half of 2018.