Two Claims Allow GSK To Show Benefit For Each Breo Component In COPD
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Lung function studies failed to demonstrate that the inhaled corticosteroid fluticasone furoate contributes to bronchodilation when added to the LABA vilanterol, but FDA was persuaded by exacerbation studies that found an added benefit from the ICS, enabling the agency to conclude each component adds benefit as required by the Combination Rule.
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