Sanofi v Amgen: Repatha ESC leavepiece headline ‘75% additional LDL‑C reduction vs placebo’ ruled misleading

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Key facts

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Case	AUTH/2800/10/15
Parties	Sanofi v Amgen
Product	Repatha (evolocumab)
Material	Six-page, gate-folded leavepiece (refs UKIE-P-145-0715-110865 and EUHQ-P-145-0715-110847, Aug 2015)
Setting	ESC Congress, London (29 Aug–2 Sep 2015)
Main claim at issue	“75% additional LDL-C reduction vs placebo” (qualified as atorvastatin 80mg + Repatha 140mg Q2W)
Evidence cited	Robinson et al (2014)
Study design notes (as cited)	Randomized, double-blind, placebo- and ezetimibe-controlled; 24 arms; 1,896 patients overall; arms ranged 55–115 patients
Arm underpinning 75% claim	Atorvastatin 80mg + evolocumab Q2W (n=109) vs atorvastatin 80mg + double-placebo
Panel view on footnotes	Footnotes should not be used to qualify otherwise misleading headlines
Applicable Code year	2015
Complaint received	20 October 2015 (PDF) / 22 October 2015 (web page)
Case completed	11 January 2016
Appeal	No appeal
Clauses breached	7.2, 7.10, 9.1
No breach	Clause 3.2
Sanctions	Undertaking received

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

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Sanofi complained about an Amgen promotional leavepiece for Repatha (evolocumab) distributed at the European Society of Cardiology (ESC) Congress in London (29 Aug–2 Sep 2015).
The front cover headline claim stated: “75% additional LDL-C reduction vs placebo”, referenced to Robinson et al (2014).
The 75% figure came from one specific treatment arm: evolocumab every 2 weeks plus atorvastatin 80mg (n=109) vs atorvastatin 80mg plus double-placebo.
The leavepiece footnote referenced the overall study size (1,896 patients) but did not explain that individual arms were much smaller (55–115 patients per arm).
The leavepiece positioned the claim above therapeutic indications; Sanofi argued this implied the result applied broadly across indicated patients.
Amgen argued the claim reflected a co-primary endpoint comparison vs placebo, was clinically relevant to UK practice (atorvastatin 80mg), was consistent with the SPC, and had been pre-vetted by the MHRA.

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No breach of Clause 3.2 (the Panel did not consider the positioning made the claim inconsistent with the SPC).
Breach of Clause 7.2 (information not sufficiently complete / not presented to allow readers to form their own opinion of clinical significance).
Breach of Clause 7.10 (prominence of the 75% vs placebo result in a small cohort exaggerated general efficacy; not applicable to all eligible patients).
Breach of Clause 9.1 (high standards not maintained).
No appeal.

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