GSK breached ABPI Code over broad QoL comparison claim for Trelegy Ellipta COPD ad

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Key facts

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Case number	AUTH/3260/10/19
Company	GlaxoSmithKline UK Limited
Product	Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol)
Material	Website advertisement on Primary Care Respiratory Society site (ref UK/TLY/0035/17K)
Date of material	November 2018
Main claim at issue	“Improvement in quality of life vs ICS/LABA”
Complainant	Concerned UK health professional
Complaint received	14 October 2019
Case completed	03 August 2020
Applicable Code year	2019
Breach clauses	7.2, 7.3, 7.4
Appeal	No appeal
Sanctions	Undertaking received; Additional sanctions: Not stated

Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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A UK health professional complained about a Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) advertisement (ref UK/TLY/0035/17K) placed on the Primary Care Respiratory Society website in November 2018.
The ad headline was “Less to take. More to take in” and included the claims “The only COPD triple therapy delivered in a single daily inhalation” and “Improvement in quality of life vs ICS/LABA”.
The complaint focused on “Improvement in quality of life vs ICS/LABA”, which cited the FULFIL trial (Lipson et al 2017) comparing Trelegy only to Symbicort Turbohaler (budesonide/formoterol), not the whole ICS/LABA class.
GSK argued the claim was supported by FULFIL (QoL co-primary endpoint), plus IMPACT (Lipson et al 2018; QoL as a secondary outcome vs Relvar Ellipta) and indirect support via Calverley et al 2010 (Fostair non-inferior to Symbicort for QoL).
The Panel considered the wording “vs ICS/LABA” implied a class-wide comparison (i.e., against all ICS/LABA combinations), not just the specific comparators studied.

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The Panel ruled the claim did not reflect the evidence clearly and was misleading by implication.
The comparison was ruled misleading and incapable of substantiation.
Breaches were ruled under Clauses 7.2, 7.3 and 7.4.
No appeal.

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