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

 
• By Sue Sutter
  
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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

To secure mortality benefit labeling language for its chronic obstructive pulmonary disease drug Trelegy Ellipta, GlaxoSmithKline plc will have to overcome US Food and Drug Administration skepticism about the design and results of the IMPACT trial, including questions as to whether the survival benefit seen was driven by the abrupt withdrawal of inhaled corticosteroid treatment for some randomized subjects.

In a briefing document released ahead of a 31 August advisory committee meeting, the agency cites “statistical and clinical...

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