GSK fined for ambiguous Trelegy website claim implying significant exacerbation reduction vs unnamed triple therapy (AUTH/3781/6/23)

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Key facts

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Case number	AUTH/3781/6/23
Company	GSK
Complainant	Anonymous, contactable complainant (health professional)
Product	Trelegy Ellipta (fluticasone furoate, umeclidinium, vilanterol)
Channel/material	Promotional webpage on GSK.pro (Trelegy Ellipta section), clinical data subsection
Material ID	PM-GB-FVU-WCNT-200013 (V8.0)
Core issue	Ambiguous headline comparative claim implying statistically significant exacerbation reduction vs an unnamed single-inhaler triple therapy
Reference cited on page	Ismaila et al. (2022) (copy not provided to the Panel)
Applicable Code year	2021
Breach clauses	5.1, 6.1, 6.2
No breach clauses	2
Sanctions	Undertaking received; additional sanctions not stated
Complaint received	21 June 2023
Case completed	25 September 2024
Appeal	No appeal

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

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An anonymous, contactable health professional complained about a promotional claim on GSK’s HCP website (GSK.pro) for Trelegy Ellipta.
The headline claim stated: “Trelegy demonstrated greater annualised moderate/severe exacerbation reduction vs. another COPD single-inhaler triple therapy”.
The complainant alleged the claim was misleading because there were two other UK single-inhaler triple therapies (Trixeo and Trimbow) and the claim did not specify which comparator it referred to.
GSK explained the claim was based on a GSK network meta-analysis comparing Trelegy, Trimbow and Trixeo; Trelegy was statistically significantly better vs Trixeo but not vs Trimbow.
The webpage placed the headline claim prominently at the top; the qualifying graphic comparing Trelegy vs Trixeo and vs Trimbow was further down the page and required scrolling.
GSK acknowledged the claim was misleading and accepted breaches of Clauses 6.1, 6.2 and 5.1, but denied Clause 2.
GSK stated an experienced signatory had advised the claim should be explicit that significance was only versus Trixeo, but that advice was not followed (GSK cited commercial pressure and a competitive marketplace).

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Breach of Clause 6.1 Making a misleading claim.
Breach of Clause 6.2 Making an unsubstantiated claim.
Breach of Clause 5.1 Failing to maintain high standards.
No Breach of Clause 2 Requirement that activities or materials must not bring discredit upon, or reduce the confidence in, the pharmaceutical industry.

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