AUTH/3522/6/21: Health professional v GlaxoSmithKline (Trelegy Ellipta) – No breach | PMCPA Case

📊

Key facts

⌄

Case number	AUTH/3522/6/21
Complainant	Health professional
Company	GlaxoSmithKline UK Limited
Product	Trelegy Ellipta (fluticasone/umeclidinium/vilanterol)
Therapy area	COPD
Materials	BTS Winter Meeting supplement ad (PM-GB-FVU-JRNA-200003 (v2.0)); gskpro webinar ad (PM-GB-RS-WCNT-210009)
Main allegations	Implied use in all COPD (including mild); comparator claim too broad due to Symbicort strength ambiguity; webinar page misleading without indication stated
Applicable Code year	2019
Clauses cited	2, 3.2, 7.2, 7.3, 7.4, 9.1
Panel decision	No breach
Complaint received	14 June 2021
Case completed	3 August 2021
Appeal	No appeal

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

🤖

Got a question about this case?

Ask one of our 13 specialist ABPI advisors — instant answers, 24/7.

Ask AskAnzal AI

🎬 Expert Video Walkthrough

🎬

Video walkthrough — coming for members

Subscribe now and get expert video analysis for every case as we publish them.

Subscribe — from £299/yr

📋

⌄

A health professional complained about promotion of Trelegy Ellipta (fluticasone/umeclidinium/vilanterol) by GlaxoSmithKline UK Limited.
Materials complained about:
- BTS Winter Meeting (Feb 2021) supplement advertisement (ref PM-GB-FVU-JRNA-200003 (v2.0)).
- gskpro website advertisement for a promotional webinar (ref PM-GB-RS-WCNT-210009) titled “Single Inhaler Triple Therapy in COPD; Evidence to Action”.
Key issues raised by the complainant:
- The BTS ad headline claim (“For patients with COPD on treatment with ICS/LABA who are symptomatic and at risk of an exacerbation*”) allegedly implied Trelegy could be used for any COPD patient (including mild COPD) and was not aligned to the licensed indication.
- The BTS ad comparative claim versus Symbicort Turbohaler allegedly failed to specify which Symbicort strength/dose was used in the cited trial, making the claim broader than the evidence.
- The webinar webpage allegedly implied Trelegy was licensed for all COPD patients and was misleading because the licensed indication was not stated on the page.

⚖️

⌄

No breach of the Code was ruled in relation to all allegations.
The Panel considered the COPD stepwise treatment approach and HCP familiarity with guidelines when assessing whether the materials implied use in mild COPD or “all COPD”.
The Panel considered the Symbicort comparison was not broader than the evidence, noting only one delivered dose is licensed for COPD (with two presentations achieving the same delivered dose).

🔒

Members get the complete breakdown — Clauses, Sanction, Signatory Lens, Audit checklist, and 3 Key Questions.

Best value

£249/year

Annual — save £99

£29/mo

Monthly

Join Now — Instant Access