Striverdi Exercise Trials Tried, But Failed, To Control For Non-Disease Impacts
This article was originally published in Pharmaceutical Approvals Monthly
FDA questioned adherence to, and effectiveness of, measures aimed at minimizing exercise test performance variability in the trial Boehringer Ingelheim conducted to support exercise-related labeling claims for the COPD drug.
You may also be interested in...
A timeline chronicling the development of Boehringer Ingelheim’s chronic obstructive pulmonary disease treatment olodaterol.
FDA staff that participated in the review of Boehringer Ingelheim’s olodaterol for chronic obstructive pulmonary disease.
Sponsor’s claimed impact on exercise tolerance was not adequately supported and should not serve as a marketing advantage for the chronic obstructive pulmonary disease drug, FDA review staff said. However, Boehringer Ingelheim’s failed attempt for the exercise-related labeling language spurred the agency to clarify the types of studies and endpoints that potentially could support such claims.