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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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.
The long-acting beta agonist olodaterol cleared FDA for treatment of chronic obstructive pulmonary disease, but it didn’t gain the differentiating claim the German pharma was seeking.