GSK breached ABPI Code over Relvar Ellipta ‘superior’ asthma control ad lacking context (AUTH/3229/7/19)

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Key facts

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Case number	AUTH/3229/7/19
Company	GlaxoSmithKline UK Limited
Complainant	‘Concerned UK health professional’
Medicine	Relvar Ellipta (fluticasone furoate/vilanterol)
Material	Two-page advertisement in Pulse (April 2019)
Main claim at issue	“Relvar Ellipta was superior to other ICS/LABAs (usual care) in helping more patients improve asthma control in everyday clinical practice in the Salford Lung Study”
Key study referenced	Salford Lung Study (Phase 3b open-label, randomised, controlled, two-arm superiority trial; asthma patients aged ≥18)
Panel’s core concern	Insufficient context (limitations, ACT details, population differences) leading to misleading/exaggerated impression and misleading comparison
Applicable Code year	2019
Complaint received	26 July 2019
Case completed	9 December 2019
Appeal	No appeal
Clauses breached	7.2, 7.3, 7.4, 7.10, 9.1
No breach clauses	3.2
Sanction	Undertaking received

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

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A ‘concerned UK health professional’ complained about a two-page Relvar Ellipta (fluticasone furoate/vilanterol) advertisement placed in Pulse (April 2019) by GlaxoSmithKline UK Limited.
Page 1 asked: “Which ICS/LABA helps more patients improve asthma control?” (with “helps more” and “asthma control” prominent).
Page 2 claimed: “Relvar Ellipta was superior to other ICS/LABAs (usual care) in helping more patients improve asthma control in everyday clinical practice in the Salford Lung Study”, with a note that data were from a subset of the PEA population prescribed ICS/LABA at randomisation.
The complainant alleged the ad lacked statistics/context, implied superiority not supported by the SPC evidence base, and promoted off-licence / exaggerated use.
The Panel focused on whether the Salford Lung Study results were presented with sufficient context (including limitations) and whether readers could form their own view of therapeutic value.

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Breach found of Clauses 7.2, 7.3, 7.4, 7.10, 9.1.
No breach of Clause 3.2 (promotion not found inconsistent with the SPC on balance, despite the first-page question not specifying which patients were on treatment).
Panel considered the ad misleading because it did not set Salford Lung Study results in context (limitations and other study data), leading readers to assume applicability to all eligible patients.

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