GSK’s Trelegy Ellipta: US FDA Panel To Weigh Role Of Inhaled Corticosteroids On Mortality Results

 
• By Sue Sutter

GSK wants labeling to reflect all-cause mortality results from the 10,355-patient IMPACT trial of the triple-combination therapy for COPD, but FDA questions whether the survival benefit was driven by the abrupt halt in inhaled corticosteroid treatment for some randomized subjects.

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GSK recognizes that mortality benefit labeling is a high bar given the absence of such a claim for other approved COPD therapies. • Source: Shutterstock

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