US FDA Panel Rejects Trelegy Ellipta COPD Mortality Claim; Worries Include Potential Overuse

 
• By Sue Sutter

Survival benefit seen in GlaxoSmithKline’s IMPACT study may be due to negative effects of abrupt withdrawal of inhaled corticosteroids for some patients instead of benefits of the triple-combination therapy itself, advisory committee members said.

FDA Advisory Committee Feature image
Panel votes 14-1 against mortality benefit labeling for Trelegy Ellipta.

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