Novo Nordisk detail aid for Victoza: composite endpoint design ruled misleading (AUTH/2569/12/12)

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Key facts

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Case number	AUTH/2569/12/12
Complainant	Merck Sharp & Dohme Limited
Respondent	Novo Nordisk Limited
Product	Victoza (liraglutide)
Material	Detail aid “The value of Victoza” (ref UK/LR/0212/0048)
Main issue	Prominent red-box display of composite endpoint (“HbA1c<7% + weight loss/neutrality + no hypos”) created a misleading impression
Key references mentioned	Zinman et al (2011); Pratley et al (2010); data on file (2011)
Complaint received	17 December 2012
Case completed	25 February 2013
Applicable Code year	2012
Breach findings	Clause 7.2 (misleading presentation of composite endpoint)
No breach findings	Clause 3.2; Clause 7.2 (sitagliptin comparison); Clause 8.1
Sanction	Undertaking received
Appeal	No appeal

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

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Merck Sharp & Dohme (MSD) complained about a Novo Nordisk Victoza (liraglutide) detail aid titled “The value of Victoza” (ref UK/LR/0212/0048).
The detail aid used a meta-analysis (Zinman et al, 2011) and repeatedly displayed a “triple composite endpoint” as three prominent red boxes joined by plus signs: “HbA1c<7%” + “weight loss or neutrality” + “no hypos”.
The red boxes were placed close to benefit claims and the Victoza logo, using the same shade of red, and appeared on multiple pages including the back cover.
MSD alleged: (a) inclusion of monotherapy trial data (LEAD-3 Mono) in the meta-analysis meant off-label data were used (Clause 3.2); (b) the red-box composite endpoint presentation was misleading given hypoglycaemia is listed as common/very common in the SPC (Clause 7.2); and (c) the comparison with sitagliptin (Januvia) was misleading and possibly disparaging (Clauses 7.2 and 8.1).
Novo Nordisk stated the detail aid did not promote monotherapy; the licensed indication as combination therapy was on the front page; and the red boxes were intended as a reminder of the composite endpoint used in Zinman et al.

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No breach of Clause 3.2 (Panel did not consider that reporting Zinman et al per se promoted Victoza for an unlicensed indication or was inconsistent with the SPC, on the narrow grounds of the allegation).
Breach of Clause 7.2 (Panel ruled the presentation of the composite endpoint in prominent red boxes was, in effect, a claim for Victoza and misleading).
No breach of Clause 7.2 for the sitagliptin comparison (despite the Clause 7.2 breach on the composite endpoint presentation).
No breach of Clause 8.1 (comparison did not disparage sitagliptin).
No appeal.

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