FDA Advisory Committee announces recommendation on the inclusion of mortality data in Trelegy Ellipta prescribing information

31 August 2020​

Issued: London UK

The US FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) has voted that data from the IMPACT trial do not provide substantial evidence to support the labelling claim that Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol ‘FF/UMEC /VI) improves all-cause mortality in patients with COPD.

We respect the recommendation of the Advisory Committee and we value the clinically and scientifically important conversations held today.  We remain confident that the totality of the IMPACT data demonstrate the important role Trelegy Ellipta continues to have on improving outcomes for the many people who are living with COPD.

According to the World Health Organisation, COPD is the third-leading cause of death globally, so it is understandable that reduction in risk of all-cause mortality is an important efficacy endpoint that physicians look for in their treatment options for this disease.

While we are disappointed with the committee’s recommendation, the fact that no pharmacological treatment for COPD includes data on a reduction in risk of all-cause mortality in the label highlights how challenging it is to demonstrate this evidence.  

Advisory committees provide independent, expert advice on scientific, technical, and policy matters related to the development and evaluation of products regulated by FDA. They provide non-binding recommendations for consideration by the FDA, with the final decision on approval made by the FDA. Following today’s recommendation, we plan to work with the FDA to determine next steps.