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PMCPA Case

AUTH/2141/7/08: Novo Nordisk v Sanofi-Aventis – Promotion of Lantus (claims on 24-hour efficacy and hypoglycaemia risk)

📅 8 March 2026 | 🖉 Dr Anzal Qurbain
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Key facts

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Case numberAUTH/2141/7/08
Case referencePromotion of Lantus
ComplainantNovo Nordisk
Respondent/companySanofi-Aventis
Product(s)Lantus (insulin glargine); comparator referenced: Levemir (insulin detemir)
Material/channelFour leavepieces (LAN07/1333; LAN08/1037; LAN08/1038; LAN08/1039) and a mailer (LAN08/1041)
Key issueWhether “24-hour efficacy” implied prohibited “24-hour control” in context; whether a comparative graph and a hypoglycaemia claim based on pooled observational data were misleading/disparaging; and whether high standards/undertakings were met
Dates (received/completed if stated)Received 14 July 2008; completed 28 October 2008
AppealYes. Sanofi-Aventis appealed multiple Panel rulings; some were overturned (undertaking/Clause 2/9.1 for “24-hour efficacy” context; graph misleading/disparaging; mailer hypoglycaemia claim), and some upheld (LAN08/1038 hypoglycaemia claim misleading and high standards breach).
Code year2008 Code (noted clauses same as 2006 except Clause 22 renumbered as Clause 25)
Breaches/clausesFinal upheld breaches: Clause 7.2 and Clause 9.1 (for hypoglycaemia claim in LAN08/1038). Other alleged/Panel breaches were overturned on appeal or not upheld.
SanctionsNo explicit additional sanctions stated beyond the required undertaking/corrective actions described in the report

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

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What happened

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  • Novo Nordisk complained about Sanofi-Aventis’ promotion of Lantus (insulin glargine); Novo Nordisk marketed Levemir (insulin detemir).
  • Materials at issue: four leavepieces (LAN07/1333; LAN08/1037; LAN08/1038; LAN08/1039) and a mailer (LAN08/1041).
  • Claim 1: “24-hour efficacy” appeared as part of the Lantus product logo in one leavepiece and as “Once daily – provides 24-hour efficacy” in the other materials.
  • Novo Nordisk argued the “24-hour efficacy” claim was insufficiently substantiated and, in some contexts, implied “24-hour control”, which it said was prohibited by an undertaking from Case AUTH/2028/7/07.
  • Novo Nordisk also objected to use of a Porcellati et al (2007b) graph comparing Lantus and Levemir, alleging cherry-picking and that it misled and disparaged Levemir.
  • Claim 2: “In clinical practice, after switching from other treatments, Lantus is associated with a lower risk of hypoglycaemia compared to insulin detemir” appeared in leavepiece LAN08/1038 and mailer LAN08/1041, referenced to Currie et al (2007), a retrospective GP database analysis using pooled type 1 and type 2 data.
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Outcome

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  • Claim 1 (24-hour efficacy) – context/undertaking: The Panel ruled that in LAN08/1037 and LAN08/1038, the claim “Once daily – provides 24-hour efficacy” appearing under the headline “Lantus – control without compromise for your diabetes patients” implied “24-hour control” and breached the undertaking (Clause 25), and also ruled breaches of Clauses 9.1 and 2. On appeal, the Appeal Board ruled no breach of Clause 25 and consequently no breach of Clauses 9.1 and 2 for these items.
  • Claim 1 (24-hour efficacy) – substantiation: The Panel ruled that in LAN07/1333, LAN08/1039 and LAN08/1041, “24-hour efficacy” could be substantiated in context as a duration-of-action claim (including reference to SPC section 5.1 showing activity profile between 9 and 24 hours in type 1 diabetics) and ruled no breach of Clause 7.4 (not appealed).
  • Porcellati graph (LAN08/1039 and LAN08/1041): The Panel ruled the graph misleading (Clause 7.2) and disparaging of Levemir (Clause 8.1). On appeal, the Appeal Board ruled no breach of Clauses 7.2 and 8.1.
  • Claim 2 (hypoglycaemia risk) – LAN08/1038: The Panel ruled that because LAN08/1038 was specifically about use of Lantus in type 2 diabetics, a hypoglycaemia claim based on pooled type 1 and type 2 data was misleading (breach of Clause 7.2) and that repeating misleading use of pooled data meant high standards had not been maintained (breach of Clause 9.1). The Appeal Board upheld breaches of Clauses 7.2 and 9.1.
  • Claim 2 (hypoglycaemia risk) – LAN08/1041: The Panel ruled the claim misleading (breach of Clause 7.2) but no breach of Clause 9.1 and no breach of Clause 8.1. On appeal, the Appeal Board ruled no breach of Clause 7.2 because the mailing referred to both type 1 and type 2 diabetes patients.
  • Complaint received 14 July 2008; case completed 28 October 2008.
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