AUTH/2604/5/13 - Novo Nordisk v Sanofi

Promotion of Lyxumia

  • Received
    13 May 2013
  • Case number
    AUTH/2604/5/13
  • Applicable Code year
    2012
  • Completed
    26 June 2013
  • Breach Clause(s)
    7.2 (x2) and 7.3
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal
  • Review
    August 2013

Case Summary

Novo Nordisk complained about a Lyxumia (lixisenatide) advertisement issued by Sanofi and published in the Health Service Journal. Lyxumia was a selective glucagon-like peptide-1 (GLP-1) receptor agonist.

The detailed response from Sanofi is given below.

Novo Nordisk alleged that the emphasis on 'only once-daily' in the claim 'Lyxumia is the only oncedaily GLP-1 receptor agonist licensed for type 2 diabetes mellitus patients not optimally controlled on oral antidiabetic drugs and/or basal insulin' was misleading. It implied that Lyxumia was the only once daily GLP-1 receptor agonist available, which was not so. Novo Nordisk also stated that the claim could be read with omission of the word 'and', thereby referring to the use of Lyxumia in combination with oral antidiabetic drugs only. As its product Victoza was also a once-daily GLP-1 receptor agonist for use with oral antidiabetic drugs, it was misleading to use the word 'only' in this context.

The Panel considered that emboldening 'only oncedaily' in the claim 'Lyxumia is the only once-daily GLP-1 receptor agonist licensed for type 2 diabetes mellitus patients not optimally controlled on oral antidiabetic drugs and/or basal insulin', implied that Lyxumia was the only once-daily GLP-1 receptor agonist which was not so; Victoza was also a oncedaily GLP-1 receptor agonist. Lyxumia and Victoza were both licensed as adjunctive therapy – to be added to existing antidiabetic therapy to achieve improved glycaemic control. Lyxumia could also be added to an existing treatment regimen which included insulin. The Panel accepted that, in the round, this claim was true, but considered that the 'and/or' made it unclear as to what 'only' referred to. Whilst the latter two treatment scenarios were correct in that only Lyxumia could be added to existing insulin therapy, the first was not; both Victoza and Lyxumia could be given to patients not currently controlled on OAD therapy. The Panel considered that the claim was misleading and ambiguous and a breach of the Code was ruled.

Novo Nordisk further alleged that the claims 'Lyxumia leads to even greater costs savings' and 'Turn to the GLP-1 that minimises costs' implied Lyxumia could save costs vs other available treatments. Such a comparison did not take into account the difference in efficacy and safety between similar treatments and was therefore alleged to be misleading, inaccurate and unfair.

In the Panel's view the claim 'Turn to the GLP-1 that minimises costs' would be read as an indirect comparison of Lyxumia with all other GLP-1receptor agonists. The claim 'Lyxumia leads to even greater cost savings of:' appeared in the body of the advertisement above two stab points which referred respectively to a 26% saving vs Bydureon (exenatide) 2mg once-weekly and Victoza 1.2mg once-daily and a 51% saving vs Victoza 1.8mg once-daily. Without the benefit of more information, it was not clear that the claims were only based on acquisition costs and not a costeffectiveness analysis or similar. In that regard the Panel considered that the claims as well as the comparisons were misleading and breaches of the Code were ruled.