AstraZeneca v GSK: Trelegy COPD NMA headline claim ruled misleading (AUTH/3699/10/22)

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Key facts

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Case number	AUTH/3699/10/22
Complainant	AstraZeneca
Respondent	GSK
Complaint received	18 October 2022
Case completed	18 December 2023
Applicable Code year	2021
Appeal	No appeal
Therapy area	Chronic Obstructive Pulmonary Disease (COPD)
Product	Trelegy Ellipta (Fluticasone Furoate/Umeclidinium/Vilanterol; FF/UMEC/VI)
Comparator mentioned	Trixeo Aerosphere; Trimbow pMDI
Materials	GSKpro HCP promotional webpage and embedded video (updated versions considered)
Main issue	Comparative promotional headline based on NMA created a misleading impression of statistical/clinical significance
Breach clauses	Clause 5.1; Clause 6.1; Clause 14.1
No breach clauses	Clause 2; Clause 3.3; Clause 6.1 (Requirement that comparisons must not be misleading); Clause 6.6
Sanctions	Undertaking received

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

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AstraZeneca complained about GSK’s UK HCP promotional webpage and embedded video on the Trelegy (FF/UMEC/VI) GSKpro site, which presented results from a published Network Meta-analysis (NMA) in COPD.
The materials made comparative claims versus other single-inhaler triple therapies (SITTs), including AstraZeneca’s Trixeo, based on a frequentist fixed-effect (FE) model NMA.
Key claims included a headline: “Greater annualised moderate/severe exacerbation reduction vs. other COPD single-inhaler Triple Therapies” and a specific claim: “38% fewer exacerbations (vs. Trixeo Aerosphere); IRR: 0.62 (95% CI: 0.45, 0.86); p=0.0044”.
AstraZeneca alleged the NMA methodology and selective reporting (FE emphasised; RE not fully presented) made the promotional comparisons misleading, unbalanced and potentially disparaging; it also alleged breach of a prior undertaking (Case AUTH/3229/7/19).
GSK stated the webpage/video had been updated following inter-company dialogue; the Panel ruled on the updated versions.

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Breach of Clause 6.1 (Making a misleading claim).
Breach of Clause 14.1 (Making a misleading comparison).
Breach of Clause 5.1 (Failing to maintain high standards).
No breach of Clause 6.6 (Requirement that another company’s medicines must not be disparaged).
No breach of Clause 3.3 (Requirement to comply with an undertaking).
No breach of Clause 2 (Requirement that activities or materials must not bring discredit upon, or reduce confidence in, the pharmaceutical industry).
No breach of Clause 6.1 (Requirement that comparisons must not be misleading) as listed in the case outcome summary.

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