AstraZeneca v Eli Lilly and Daiichi-Sankyo: Efient leavepiece and 15‑month claims vs 12‑month recommended treatment

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Key facts

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Case numbers	AUTH/2506/5/12 and AUTH/2507/5/12
Complainant	AstraZeneca UK Limited
Respondents	Eli Lilly and Company Limited; Daiichi-Sankyo UK Limited
Material	Efient (prasugrel) leavepiece, 4 pages, ref UKEFF00714a
Medicine / therapy area	Efient (prasugrel) antiplatelet; ACS/STEMI patients undergoing PCI, co-administered with ASA
Main issue	Prominent 15‑month efficacy/safety presentations and claims, insufficiently contextualised against SPC recommendation of treatment up to 12 months; unbalanced safety presentation
Key studies cited	TRITON‑TIMI 38; Montalescot et al (2009); Murphy et al (2008)
Applicable Code year	2011
Complaint received	11 May 2012
Case completed	31 August 2012
Appeal	No appeal
Breach clauses	Clause 2, Clause 3.2, Clause 7.2, Clause 7.9, Clause 9.1
Sanctions	Undertaking received; Additional sanctions: Advertisement

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

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What happened

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AstraZeneca complained about a four-page Efient (prasugrel) leavepiece (ref UKEFF00714a) issued by Eli Lilly and Company Limited and Daiichi-Sankyo UK Limited.
Efient (with acetylsalicylic acid) was indicated for prevention of atherothrombotic events in ACS/STEMI patients undergoing PCI; the SPC (Section 4.2) stated: “A treatment of up to 12 months is recommended unless discontinuation of Efient is clinically indicated”.
The leavepiece focused on the STEMI subgroup of TRITON‑TIMI 38 and presented multiple prominent efficacy/safety graphics and claims at 15 months (450 days), including RRR arrows and less prominent ARR figures.
Page 1: a graph titled as a pre-specified STEMI subgroup analysis of the primary efficacy endpoint and key safety endpoint at 15 months; included a dotted line labelled “Recommended length of treatment” around 365 days, but the 15‑month results were visually dominant and there was no 12‑month ARR/RRR presented.
Page 2: a bar chart on stent thrombosis at 15 months and a landmark analysis graph of time from first to second event up to 450 days; again, 15‑month results were prominent and 12‑month recommendation was not prominent on the page.
Page 3 included the bullet claim: “No significant difference in non-CABG TIMI major bleedings in STEMI and diabetes patients”, without contextualising the overall TRITON‑TIMI 38 bleeding outcomes (which were worse for Efient vs clopidogrel in the overall study).
The companies argued the SPC referenced median follow-up of 14.5 months (Sections 5.1 and 4.8) and that “recommended up to 12 months” appeared multiple times (strapline, dotted lines, prescribing information). They also noted the Montalescot graph had been pre-vetted by MHRA in 2009.
The leavepiece was withdrawn in May 2012 to make changes.

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Outcome

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Breach rulings: Clause 2, Clause 3.2, Clause 7.2, Clause 7.9 and Clause 9.1.
The Panel accepted that 15‑month data could be of interest and that the SPC referred to data beyond 12 months, but ruled that references beyond 12 months should be secondary to, and placed in context of, the SPC’s Section 4.2 recommendation (up to 12 months).
The Panel found the design and prominence of 15‑month headings/results meant the material was misleading about the recommended treatment period and in effect promoted 15 months’ treatment.
The Panel found the safety presentation was not balanced: subgroup “no significant difference” statements were not placed in the context of overall TRITON‑TIMI 38 bleeding outcomes and author caveats; high standards were not maintained.
Given the overall circumstances—particularly safety presentation—the Panel ruled a breach of Clause 2 (a particular sign of censure).
No appeal.

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