AUTH/3719/12/22: GSK – Trelegy website claims, NMA presentation and Ellipta device messaging

📅 2022 | 🖉 Dr Anzal Qurbain
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Key facts

Case numberAUTH/3719/12/22
PartiesChiesi/Director v GSK UK Limited
Material typeWebsite pages (Trelegy on GSKPro), embedded video, ERS 2022 leavepiece, banner advertisement
Therapy areaCOPD (single-inhaler triple therapy)
Products referencedTrelegy Ellipta; Ellipta device; competitor inhalers depicted included Fostair (Chiesi), Braltus (Teva), Salamol (Teva) (as confirmed during dialogue)
Main issuesAmbiguous “only choice…in-class superior components” claim; misleading NMA-based superiority framing and visuals; misleading/unfair Ellipta device messaging; banner ad alleged disparagement (not upheld)
Applicable Code2021 ABPI Code of Practice
Complaint received19 December 2022
Case completed14 March 2024
AppealComplainant appeal; successful on Clause 6.1/6.2 for homepage “only choice…” claim; unsuccessful on undertaking allegation
SanctionsUndertaking received; Additional sanctions: Not stated

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

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What happened

  • Chiesi complained about GSK promotional materials for Trelegy (website pages, an embedded video and an ERS 2022 leavepiece).
  • Four issues were escalated: (1) a rotating banner ad showing competitor inhalers next to a “Climate Emergency” headline; (2) “only choice with 21st century molecules & evidence of in-class superior components”; (3) claims based on a GSK-sponsored network meta-analysis (Ismaila et al 2022) implying superiority vs other single-inhaler triple therapies; (4) Ellipta device claim: “Don’t settle for a MDI, when you can give the preferred, easy-to-use Ellipta device”.
  • Chiesi also alleged GSK breached an undertaking from a previous case (AUTH/3260/10/19).
  • Chiesi appealed Panel “no breach” rulings on: alleged breach of undertaking (Clauses 3.3/5.1/2) and the homepage version of the “only choice…in-class superior components” claim (Clauses 6.1/6.2).
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Outcome

  • No breach of Clause 6.1 and Clause 6.6 for the banner advertisement (not misleading; not disparaging). No breach of Clause 5.1 in relation to the banner advertisement.
  • Breach for the “only choice…evidence of in-class superior components” claim due to ambiguity (molecules page: Panel breach; homepage: breach at appeal).
  • Breach for NMA-based exacerbation reduction messaging and associated visuals where non-significant results (vs Trimbow) were presented in a way that misled; and for a combined lung function/exacerbation claim on the leavepiece.
  • Breach for the Ellipta device claim (“preferred” and “don’t settle for an MDI” created a misleading/unfair impression; and use of “the” implied special merit).
  • No breach of Clause 3.3 (undertaking) and therefore no breach of Clause 5.1 and Clause 2 in relation to the undertaking allegation (upheld at appeal).
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