FDA reviewers: Bronchodilation 'somewhat modest' for BI's olodaterol in COPD
This article was originally published in Scrip
Executive Summary
While data for Boehringer Ingelheim's olodaterol showed the experimental long-acting beta-agonist (LABA) at the 5mcg dose appears to have a clinically significant effect on bronchodilation in patients with chronic obstructive pulmonary disease (COPD), US FDA drug reviewers said the magnitude of that effect is somewhat modest, which they said may be related to the baseline medications allowed in the firm's 48-week trials.