AUTH/3922/6/24: Complainant v GSK — Trelegy banner alleged off-label switch claim (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/3922/6/24
Company	GSK UK Limited
Complainant	Anonymous, contactable health professional (later became non-contactable)
Medicine	Trelegy Ellipta (fluticasone furoate, umeclidinium, vilanterol)
Material	Revolving/rotating 5-frame banner advertisement on GSKPro (UK promotional site for HCPs)
Main allegation	Unlicensed/off-label promotion: implied switch from three inhalers (alleged ICS/LABA + LAMA + SABA) to Trelegy
Applicable Code	2021
Clauses considered	2; 5.1; 11.2 (x2)
Panel decision	No breach of Clauses 2, 5.1, 11.2 (x2)
Appeal	No appeal
Complaint received	8 June 2024
Case completed	17 July 2025
Material status (per company)	Withdrawn since 22 June 2023

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

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An anonymous health professional complained about a 5-frame rotating banner advert on GSK’s UK HCP promotional site (GSKPro) for Trelegy Ellipta.
The banner used an image of a COPD patient (“John”) with three inhalers on a table and rotating captions including: “58% of COPD Triple Therapy patients in UK are juggling multiple devices. Would a simpler routine make their lives easier?”
The complainant alleged the imagery/caption promoted switching from “open triple therapy” (described as ICS/LABA + LAMA + SABA) to Trelegy, which they said was outside the licence.
GSK said the material had been withdrawn since 22 June 2023 (complaint received 8 June 2024).
GSK argued the blue inhaler depicted a SABA reliever (acute use) and that “triple therapy” in this context referred to maintenance therapy (ICS/LABA + LAMA), with Trelegy being a single-inhaler triple therapy option.
The Panel assessed whether the advert promoted a switch from three inhalers including a SABA, and whether promoting simplification for “triple therapy patients” was outside the marketing authorisation.

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Clause 2 — Requirement that activities or materials must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
Clause 5.1 — Requirement to maintain high standards at all times
Clause 11.2 (x2) — Requirement that promotion of a medicine must be in accordance with the terms of its marketing authorisation and must not be inconsistent with the particulars listed in its summary of product characteristics

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