Novo Nordisk v Sanofi: Lyxumia ad ruled misleading for “only once-daily” positioning and cost-minimisation claims (AUTH/2604/5/13)

📅 2013 | 🖉 Dr Anzal Qurbain
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Key facts

Case numberAUTH/2604/5/13
PartiesNovo Nordisk v Sanofi
ProductLyxumia (lixisenatide)
ChannelAdvertisement in Health Service Journal (March 2013)
Key challenged claims“Lyxumia is the only once-daily GLP-1 receptor agonist licensed…”; “Lyxumia leads to even greater cost savings of:” and “Turn to the GLP-1 that minimises costs”
Panel findingsClaims misleading/ambiguous; cost claims and comparisons misleading as basis (acquisition cost vs cost-effectiveness) not clear
Breach clausesClause 7.2 (x2) and 7.3
Applicable Code year2012
Complaint received13 May 2013
Case completed26 June 2013
AppealNo appeal
SanctionsUndertaking received; Additional sanctions: Not stated

Download the full case report (PDF)


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

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What happened

  • Novo Nordisk complained about a Sanofi advertisement for Lyxumia (lixisenatide) published in the Health Service Journal (March 2013) (ref GBIE.LYX.13.02.11).
  • The ad included 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”, with “only once-daily” emboldened.
  • The ad also included cost-focused claims including: “Lyxumia leads to even greater cost savings of:” and “Turn to the GLP-1 that minimises costs”, alongside stated percentage savings vs Bydureon and Victoza doses.
  • During inter-company dialogue, Sanofi agreed the cost-saving comparison might invite conclusions beyond acquisition cost and said it instructed its agency not to use the ad; the ad was withdrawn from use on 29 April 2013.
  • The Panel also noted a Sanofi press release (embargoed until 00.01 on 1 May 2013) that used the phrase “cost-effective option…”, which the Panel considered implied savings beyond acquisition cost.
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Outcome

  • The Panel ruled the “only once-daily… and/or” claim was misleading and ambiguous.
  • The Panel ruled the “minimises costs” / “cost savings” claims and the associated comparisons were misleading because it was unclear they were limited to acquisition cost rather than cost-effectiveness or broader savings.
  • The advertisement had already been withdrawn by the time of the ruling.
  • No appeal.
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