AUTH/2653/11/13: Novo Nordisk v Sanofi — Lyxumia slides ruled misleading due to insufficient context from head-to-head study (Clause 7.2) | PMCPA Case

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Key facts

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Case number	AUTH/2653/11/13
Complainant	Novo Nordisk
Respondent	Sanofi
Product(s)	Lyxumia (lixisenatide); comparator referenced: Victoza (liraglutide)
Material	Promotional presentation used in remote (internet-based) sales calls; ref GBIE.LYX.13.02.15
Key slides	Slide 4 (PPG excursion claim); Slide 23 (glucagon suppression claim) (also referenced as slide 28 in parts of the report)
Study cited	Kapitza et al (2013), 28-day pharmacodynamic study with a standardised breakfast test meal
Issue	Insufficient clarity that results related to one standardised test meal and a short PD study; risk of implying broader/long-term comparative value
Applicable Code year	2012
Breach clause(s)	Clause 7.2
Complaint received	14 November 2013
Case completed	30 January 2014
Appeal	No appeal
Sanctions	Undertaking received; Additional sanctions: Not stated

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

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Novo Nordisk complained about a Sanofi promotional presentation for Lyxumia (lixisenatide) used in remote (internet-based) sales calls with health professionals (ref GBIE.LYX.13.02.15).
The presentation included comparative claims vs Victoza (liraglutide) based on Kapitza et al (2013), a 28-day pharmacodynamic study.
Slide 4 claimed: “New Lyxumia provides significantly greater reductions in PPG excursion and exposure compared with liraglutide”, supported by a graph showing post-breakfast (test meal) post-prandial glucose (PPG) excursion over ~4.5 hours.
Slide 23 (noted in parts of the report as slide 28) presented a graph and claim that Lyxumia produced greater post-meal glucagon suppression than liraglutide; the slide did not clearly reference that the data related to a single standardised test meal.
Novo Nordisk alleged Sanofi selectively presented favourable endpoints (test-meal PPG and glucagon) while omitting other clinically relevant outcomes from the same study (eg HbA1c, weight, fasting plasma glucose, and 24-hour glucose profile), making the comparison misleading.
Sanofi argued the study was designed to assess short-term pharmacodynamic differences around a standardised breakfast and that secondary endpoints (eg HbA1c, 24-hour profile) were not robust enough for promotional comparison.

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The Panel ruled the slides were misleading because it was not sufficiently clear the data came from a 28-day pharmacodynamic study and related only to one standardised test meal (not every meal of the day).
The Panel considered the slides did not provide enough information to allow readers to form their own opinion of the long-term therapeutic value of Lyxumia vs Victoza in the context of a competitor-comparison presentation.
Breach of Clause 7.2 was ruled.
No appeal.

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