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

01 Sep 2020

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.

A US Food and Drug Administration advisory committee on 31 August overwhelmingly rejected a mortality benefit labeling claim for GlaxoSmithKline plc’s chronic obstructive pulmonary disease treatment Trelegy Ellipta. The panel said it was unclear whether the survival benefit seen in the IMPACT study was due to use of the triple-combination therapy or the abrupt withdrawal of inhaled corticosteroids (ICS) for some patients.

The Pulmonary-Allergy Drugs Advisory Committee concluded the mortality findings from the 10,355-patient trial did not meet the threshold for “substantial...