Boehringer’s Novel Exercise Claims In COPD May Spur FDA Action To Clarify Requirements
Company was hoping for an exercise tolerability claim for olodaterol, but members of the Pulmonary-Allergy Drugs Advisory Committee questioned several aspects of the trials and suggested FDA issue guidance on the matter.
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Early parent involvement in drug development and clinical trial design could improve recruitment and outcomes, stakeholders argue.
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.
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.