AUTH/2600/4/13: Novo Nordisk v Sanofi – Lyxumia ‘only once-daily prandial GLP‑1’ and other claims ruled misleading/exaggerated | PMCPA Case

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Key facts

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Case number	AUTH/2600/4/13
Parties	Novo Nordisk v Sanofi
Product	Lyxumia (lixisenatide)
Therapy area	Type 2 diabetes (GLP-1 receptor agonist)
Materials	Leavepiece (GBIE.LYX.13.01.14 (PRO 20055)); one-off mailer (GBIE.LYX.13.02.02 (PRO 20140)); exhibition panels (Diabetes UK Annual Professional Conference, 13–15 March 2013)
Main claims challenged	“The only once-daily prandial GLP-1 receptor agonist”; “A positive addition can make all the difference”; “Strong evidence supporting the use of Lyxumia as add-on to basal insulin”
Complaint received	29 April 2013
Case completed	7 August 2013
Applicable Code year	2012
Breach clauses	7.2 (x2), 7.10 (x3), 8.1
Appeal	Appeal by respondent (Sanofi) – unsuccessful
Sanctions	Undertaking received; additional sanctions: Not stated

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

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Novo Nordisk complained about Sanofi promotional materials for Lyxumia (lixisenatide): a representatives’ leavepiece (ref GBIE.LYX.13.01.14 (PRO 20055)), a one-off mailer (ref GBIE.LYX.13.02.02 (PRO 20140)) and exhibition panels used at the Diabetes UK Annual Professional Conference (13–15 March 2013).
The complaint focused on three claims used across the materials/stand:
- “The only once-daily prandial GLP-1 receptor agonist”
- “A positive addition can make all the difference”
- “Strong evidence supporting the use of Lyxumia as add-on to basal insulin” (referenced to Rosenstock et al (2012) and Riddle et al (2012))
Novo Nordisk alleged the “only once-daily prandial” positioning created an artificial class distinction, was not justified by evidence, implied superiority, and disparaged Victoza (liraglutide).
Sanofi argued “prandial” meant “pertaining to a meal” and was justified by Lyxumia’s mechanism/posology and literature; it appealed the ruling on the “only once-daily prandial” claim.

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The Panel ruled the “The only once-daily prandial GLP-1 receptor agonist” claim was misleading and exaggerated, and that it disparaged Victoza.
The Appeal Board upheld the Panel’s rulings; Sanofi’s appeal was unsuccessful.
The Panel ruled “A positive addition can make all the difference” was misleading and exaggerated because it was broad and unqualified and would be associated with Lyxumia.
The Panel ruled “Strong evidence supporting the use of Lyxumia as add-on to basal insulin” exaggerated the strength of the data.

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