AUTH/2028/7/07: Novo Nordisk v Sanofi-Aventis – “24-hour glycaemic control” claims for Lantus | PMCPA Case

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Key facts

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Case number	AUTH/2028/7/07
Parties	Novo Nordisk v Sanofi-Aventis
Product	Lantus (insulin glargine)
Main issue	Promotional claims of “24-hour glycaemic control” / “24-hour control”
Materials	Posters (LAN 05/215; LAN 07/1038), leaflet (CLI 06/023), leavepiece (API 06/063), patient booklet (LAN 05/023)
Secondary issue	Distribution of “Joe’s Rough Guide to Diabetes” book with Sanofi-Aventis logo and insulin chart
Complaint received	30 July 2007
Case completed	10 January 2008
Applicable Code year	2006
Panel decision (24-hour claim)	No breach of Clauses 7.2, 7.4, 9.1
Appeal outcome (24-hour claim)	Breach of Clauses 7.2 and 7.4; no breach of Clause 9.1
Book outcome	No breach of Clauses 9.10, 18.2, 14.3
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-Aventis promotional materials for Lantus (insulin glargine) claiming “24 hour glycaemic control” / “Once daily 24-hour glycaemic control” and patient-facing references to Lantus “working for 24 hours”.
The claim appeared on posters (LAN 05/215; later LAN 07/1038), a leaflet (CLI 06/023), a leavepiece (API 06/063) and a patient booklet (LAN 05/023).
Novo Nordisk argued the claim was exaggerated/misleading and not substantiated, including because clamp data showed mean duration of action shorter than 24 hours in Lepore et al (2000) and because duration of action was dose-dependent (Klein et al, 2007). Novo Nordisk also argued the SPC did not state 24-hour glycaemic control and noted variability in action and clinical experience of some patients requiring twice-daily dosing.
Sanofi-Aventis defended the claim with clamp-study evidence (Lepore et al; Porcellati et al 2007a/2007b) and argued health professionals would understand dose considerations.
The Panel initially ruled no breach for the 24-hour glycaemic control claim; Novo Nordisk appealed.
A separate complaint concerned distribution of a book (“Joe’s Rough Guide to Diabetes”) bearing a Sanofi-Aventis logo and containing a table with insulin onset/peak/duration information alleged to be inconsistent with SPCs.

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24-hour glycaemic control claim (promotion of Lantus): On appeal, the Appeal Board ruled the claims “24-hour control” / “24-hour glycaemic control” were not capable of substantiation and were exaggerated and misleading because a once-daily dosage or 24-hour basal course of action did not equate to 24-hour glycaemic control. Breaches of Clauses 7.2 and 7.4.
High standards: No breach of Clause 9.1 (both Panel and Appeal Board).
Book (“Joe’s Rough Guide to Diabetes”): No breach of Clauses 9.10, 18.2 or 14.3 was ruled by the Panel (noting, however, the Panel queried whether the book met Code requirements given an inaccuracy in the Levemir duration entry, but those issues were not ruled as breaches on the clauses cited).

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