BI’s Olodaterol Wants Novel Exercise Claims In COPD
This article was originally published in The Pink Sheet Daily
Proposed claims for Striverdi Respimat include improved exercise tolerance and increased inspiratory capacity, but FDA has no clear regulatory pathway for them.
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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.
FDA’s Pulmonary-Allergy Drugs Advisory Committee voted 15-1 that efficacy and safety had been shown, but said the label should not imply it is a treatment for chronic bronchitis and emphysema, just airway obstruction in those conditions, as well as COPD.
Boehringer Ingelheim’s long acting beta-adrenergic agonist for chronic obstructive pulmonary disease will have to overcome LABA class issues in asthma at an advisory committee in January. The drug is up first for single-agent approval, but it is meant to be half of a combination therapy with the blockbuster treatment Spiriva.