Sanofi breached ABPI Code over Toujeo “Latest Data” app implying hypoglycaemia benefit from clamp-study PK/PD data (AUTH/2951/4/17)

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Key facts

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Case	AUTH/2951/4/17
Complainant	Consultant physician (and community diabetes specialist referenced in report)
Company	Sanofi
Product	Toujeo (insulin glargine 300U/ml)
Therapy area	Diabetes
Material/channel	Representative iPad “Latest Data app” (digital promotional material); training and briefing documents
Material reference	SAGB.TJO.16.12.1140(1)a (March 2017) (app-derived material); training ref SAGB.TJO.17.02.0144ad; briefing ref SAGB.TJO.16.12.1140(1)b
Main issue	App design and field messaging implied reduced hypoglycaemia risk was attributable to PK/PD clamp-study findings
Applicable Code year	2016
Complaint received	06 April 2017
Case completed	12 September 2017
Appeal	No appeal
Rulings	Breach: 7.2, 7.4, 9.1, 15.9; No breach: 7.2 (separate allegation re selective/incomplete data)
Sanctions	Undertaking received; additional sanctions not stated
Notable note	Post-publication note (Jan 2018) stated a third party advised Heise et al 2016 showed Tresiba had lower day-to-day and within-day variability than Toujeo; Panel ruling unchanged.

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

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A consultant physician complained about Sanofi’s promotion of Toujeo (insulin glargine 300U/ml) using a digital “Latest Data” iPad app (ref SAGB.TJO.16.12.1140(1)a, March 2017).
The app presented clamp-study data (Bailey et al 2016) on Toujeo’s steadystate PK/PD profile vs insulin degludec and also presented clinical hypoglycaemia outcomes from a different study (Bergenstal et al 2017).
The complainant alleged the material over-interpreted clamp data and implied Toujeo would significantly reduce hypoglycaemia (particularly nocturnal) in type 1 diabetes; they also alleged selective/incomplete presentation (including not addressing Heise et al).
Sanofi’s investigation identified a call on 4 April 2017 where a representative (with an area sales manager) used the iPad app and stated that “as a result of the lower PK/PD profile of Toujeo you would expect to see a lower incidence of hypos in type 1 patients.”
The Panel found the app’s layout (especially the “Latest data” first page) invited readers to link the hypoglycaemia claim to the PK/PD profile data, even though the claims were referenced to different studies and Bailey et al was not designed to measure hypoglycaemia.

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Breach: Clause 7.2 (misleading presentation) in relation to implying hypoglycaemia reduction was attributable to PK/PD findings from Bailey et al.
Breach: Clause 7.4 (claims not capable of substantiation) for the implied causal link between PK/PD profile and reduced hypoglycaemia risk.
No breach: Clause 7.2 for the separate allegation that the material was incomplete/misleading due to selective quotation/omission (the Panel did not uphold this aspect).
Breach: Clause 15.9 because training/briefing encouraged representatives to identify “clinical benefits” from Bailey et al without caution, advocating a course of action likely to breach the Code.
Breach: Clause 9.1 (failure to maintain high standards).
No appeal.

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