Sanofi breached an undertaking over a repeat “only once-daily GLP‑1RA” claim in a Nursing Times supplement (AUTH/2620/7/13)

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Key facts

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Case number	AUTH/2620/7/13
Parties	Novo Nordisk / PMCPA Director v Sanofi
Product	Lyxumia (lixisenatide) (context also included Lantus (insulin glargine) supplement)
Material	Promotional journal supplement in Nursing Times: “Lantus (insulin glargine) and the evolution of diabetes management” (ref GBIE.DIA.13.05.03)
Claim at issue	“Lyxumia is the only once-daily GLP-1RA that is licensed for use in combination with basal insulin and/or oral glucose lowering agents”
Core issue	Misleading/ambiguous “only” claim due to “and/or” wording; deemed sufficiently similar to a previously prohibited claim and therefore covered by an existing undertaking
Applicable Code year	2012
Breach clauses	Clause 2, Clause 9.1, Clause 25
Appeal	Yes (Sanofi); unsuccessful
Sanctions	Undertaking received; Advertisement; Audit of company’s procedures; Re-audit(s)
Complaint received	29 July 2013
Undertaking (case record)	20 December 2013
Case completed	16 April 2015

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

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Novo Nordisk alleged that a claim for Lyxumia (lixisenatide) in a Nursing Times promotional supplement breached an undertaking Sanofi had given in an earlier case (AUTH/2604/5/13).
The supplement (published 10 July 2013) stated: “This promotional supplement has been produced by Sanofi”.
The claim at issue (page 5) was: “Lyxumia is the only once-daily GLP-1RA that is licensed for use in combination with basal insulin and/or oral glucose lowering agents”.
The earlier case (AUTH/2604/5/13) had ruled a similar “only once-daily… and/or …” claim misleading and ambiguous; Sanofi signed an undertaking dated 25 June 2013 that use of the advertisement and “any similar material” would cease forthwith.
There was dispute about the copy deadline for the supplement (Novo Nordisk: 1 July 2013; Sanofi: 28 June 2013), but both dates were after the undertaking was signed.
Sanofi argued the supplement was different in nature and context from the earlier one-page advertisement, and that the claim reflected the marketing authorisation wording; it also said the supplement was comprehensively reviewed and certified.
The Panel and Appeal Board considered the new claim very similar to the earlier one and misleading because “and/or” made what “only” referred to unclear (particularly implying exclusivity for use with oral antidiabetic therapy where another GLP‑1RA also applied).

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Breach found: Sanofi breached its undertaking (Clause 25).
Breach found: high standards had not been maintained (Clause 9.1).
Breach found: conduct brought discredit upon and reduced confidence in the industry (Clause 2).
Sanofi appealed the rulings; the Appeal Board upheld all breaches and the appeal was unsuccessful.
Because this was the second breach of the same undertaking (following AUTH/2619/7/13), the Appeal Board required an audit of Sanofi’s Code-related procedures, followed by re-audits.
After the March 2015 re-audit, the Appeal Board decided no further action was required (subject to priority issues being addressed and continued progress).

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