AUTH/2440/10/11 & AUTH/2441/10/11: GP complaint over Trajenta press release ‘class-comparable efficacy’ claim (Boehringer Ingelheim & Lilly)

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Key facts

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Case number	AUTH/2440/10/11 and AUTH/2441/10/11
Complainant	General practitioner
Company	Boehringer Ingelheim Limited and Eli Lilly and Company Limited
Product	Trajenta (linagliptin)
Material	Press release (UK/TRJ/00004e)
Main issue	“Class-comparable efficacy” claim (in a broader statement about renal dose adjustment/monitoring)
Applicable Code year	2011
Complaint received	04 October 2011
Case completed	17 November 2011
Appeal	No appeal
Breach clauses	7.2, 7.4 and 7.10
Sanctions	Undertaking received; Additional sanctions: Not stated

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

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A general practitioner complained about a UK medical media press release (UK/TRJ/00004e) issued by Boehringer Ingelheim Limited and Eli Lilly and Company Limited at the UK launch of Trajenta (linagliptin).
The press release included the claim: “Only DPP-4 inhibitor for use in adults with type 2 diabetes mellitus offering class-comparable efficacy with no requirement for dose adjustment or additional renal monitoring in renal impairment”.
The complainant alleged the “class-comparable efficacy” element was misleading and could not be substantiated without direct head-to-head studies versus other DPP-4 inhibitors.
The companies argued head-to-head studies were not necessarily required; they relied on indirect comparisons using efficacy figures from the respective SPCs and stated the intention was to reflect similarity, not equivalence.
The Panel reviewed SPC-derived HbA1c reductions across different settings (monotherapy; add-on to metformin; add-on to metformin + sulphonylurea) and noted Trajenta’s HbA1c lowering was less than other DPP-4 inhibitors where figures were available.

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The Panel ruled the claim “class-comparable efficacy” was misleading and could not be substantiated on the data presented (indirect SPC comparisons with no way to judge clinical/statistical significance).
Breaches were ruled for Clauses 7.2 and 7.4.
The Panel also ruled the statement exaggerated Trajenta’s properties, breaching Clause 7.10.
No appeal.

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