AUTH/3331/4/20: GlaxoSmithKline – Relvar Ellipta ad in Pulse magazine (no breach) | PMCPA Case

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Key facts

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Case number	AUTH/3331/4/20
Company	GlaxoSmithKline
Product	Relvar Ellipta (fluticasone furoate/vilanterol)
Material	Advertisement in Pulse magazine (December 2019), viewed online (double page spread)
Main allegations	Generic name not adjacent to brand name; claim not supported by current data; “25% more” exaggerated and based on non-comparative data; high standards
Key claim at issue	“Choosing Relvar could help 25% more patients improve asthma control vs other ICS/LABAs” (supported by ACT responders 70% vs 56%; absolute difference 14%)
Clauses considered	4.3, 7.2, 7.3, 7.4, 7.10, 9.1
Panel decision	No breach of the Code
Complaint received	15 April 2020
Case completed	5 October 2020
Applicable Code year	2019
Appeal	No appeal

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

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A concerned UK health professional complained about a GlaxoSmithKline (GSK) advertisement for Relvar Ellipta in the December 2019 edition of Pulse magazine (viewed online).
The complainant alleged the generic name (non-proprietary name) was not next to the most prominent mention of the brand name.
The complainant also alleged the headline claim was not supported by current data and exaggerated benefit by implying it could improve “25%” of patients, arguing the underlying data were non-comparative.
The ad included the claim: “Choosing Relvar could help 25% more patients improve asthma control vs other ICS/LABAs”, with supporting text: “In a real-world study, ACT responders for Relvar were 70% vs. 56% for the other ICS/LABA arm; absolute difference 14%. Study had minimal exclusion criteria and minimal intervention.”
GSK stated the “25% more” figure was derived from the absolute difference (14%) expressed relative to the comparator response rate (14% is 25% of 56%).
GSK noted it had withdrawn the material from the publisher in December 2019 as part of consolidating Relvar materials following a prior case (AUTH/3229/7/19), though Pulse issued the item on 19 December 2019.

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No breach of the Code was found.
The Panel ruled no breach of Clause 4.3 (generic name placement for electronic advertisements).
The Panel ruled no breach of Clauses 7.2, 7.3, 7.4 and 7.10 (misleading claims, substantiation, exaggeration).
The Panel ruled no breach of Clause 9.1 (high standards).
No appeal. Applicable Code year: 2019.

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