Novo Nordisk Ozempic promotion: CV outcomes messaging not clear enough (AUTH/3245/9/19)

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Key facts

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Case	AUTH/3245/9/19
Company	Novo Nordisk
Complainant	Anonymous, contactable individual describing themself as a GP (assisted by an ex-employee during appeal)
Product	Ozempic (semaglutide), once-weekly GLP-1 RA
Main issue	Alleged off-label promotion for weight loss and CV superiority; clarity/completeness of CV outcomes presentation (SUSTAIN 6 non-inferiority vs superiority messaging)
Materials referenced	Leavepieces UK19OZM00122 and UKOZM00181; iDetailer UKOZS03180001; briefing document “Ozempic Core Launch Guide”
Decision	Breach of Clauses 7.2 and 9.1; no breach of Clause 3.2 and Clause 2 (and others listed)
Sanctions	Undertaking received; additional sanctions not stated
Complaint received	23 September 2019
Case completed	11 March 2020
Applicable Code year	2019

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

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An anonymous, contactable individual describing themself as a GP (later noted to be assisted by an ex-employee during the appeal) complained about Novo Nordisk representatives’ promotion of Ozempic (semaglutide).
The complainant alleged off-label promotion around weight loss and cardiovascular (CV) benefits/superiority, including that SUSTAIN 6 was not powered for superiority.
The complainant also alleged the representative could not substantiate claims, failed to provide more information, and denigrated dapagliflozin, sitagliptin and canagliflozin (but provided limited detail and did not provide the specific leavepiece).
Novo Nordisk provided two leavepieces (UK19OZM00122; UKOZM00181), an iDetailer (UKOZS03180001) and briefing material (“Ozempic Core Launch Guide”).
Panel focus: whether promotion was consistent with the SPC/indication, and whether CV outcomes presentation was sufficiently clear/complete given SUSTAIN 6’s non-inferiority design and the way results were presented.

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No breach of Clause 3.2 (promotion in accordance with marketing authorisation / not inconsistent with SPC) regarding alleged off-label promotion for weight loss and CV outcomes (upheld on appeal).
Breach of Clause 7.2 because CV outcomes information was not sufficiently clear/complete for recipients to form their own opinion of therapeutic value, given the non-inferiority primary endpoint and cautions about superiority.
Breach of Clause 9.1 (high standards) in relation to the above.
No breach of Clause 2 (and other clauses considered) due to lack of substantiated evidence from the complainant; no Clause 2 breach was upheld on appeal.

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