AUTH/3427/11/20: Lilly v Novo Nordisk — CVOT slide deck comparisons (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/3427/11/20
Parties	Eli Lilly and Company Limited v Novo Nordisk Ltd
Material	Promotional slide decks about CVOTs in type 2 diabetes (refs UK19OZM00368 Nov 2019; UK20DI00110 April 2020)
Key slide referenced	UK19OZM00368 slide 24 (“GLP-1RA CVOTs – Primary outcomes” with a note that direct comparisons should not be made)
Products mentioned	Victoza (liraglutide), Ozempic (semaglutide), Trulicity (dulaglutide) (and albiglutide/HARMONY shown on slide 24)
Allegations	Misleading/incomplete presentation and implied comparisons; lack of clarity on generalisability (primary vs secondary prevention); failure to encourage rational use; failure to maintain high standards
Clauses cited	7.2, 7.3, 7.10, 9.1
Applicable Code year	2019
Complaint received	18 November 2020
Case completed	16 June 2022
Outcome	No breach
Appeal	Appeal by the complainant; no breach upheld (with a procedural set-aside and rehearing for some clauses)

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

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Eli Lilly complained about two Novo Nordisk slide decks on cardiovascular outcome trials (CVOTs) in type 2 diabetes (refs UK19OZM00368 Nov 2019 and UK20DI00110 April 2020).
The complaint focused on how GLP-1RA CVOT primary outcomes were presented side-by-side (notably slide 24 of UK19OZM00368), which Lilly said invited inappropriate comparisons.
Lilly alleged the deck did not make clear differences in generalisability of CV benefit across populations (primary vs secondary prevention), particularly:
- LEADER (liraglutide/Victoza) and SUSTAIN-6 (semaglutide/Ozempic): benefit said to be confined to established CVD (secondary prevention).
- REWIND (dulaglutide/Trulicity): benefit said to extend to patients without established CVD (primary prevention) as well.
Novo Nordisk said the decks were intended as an overview/education on CVOTs, showed only primary endpoints consistently (no selective secondary endpoints), and included statements that direct comparisons should not be made due to trial design differences.
The Panel noted slide 24’s layout inevitably invited comparison, despite the subheading warning against direct comparisons.
Procedurally, the Panel ruled on UK19OZM00368 because it considered the complaint’s allegations were directed at that deck; at appeal, both parties argued the case concerned both decks, but no combined deck was provided.

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No breach of the ABPI Code of Practice (2019) was ruled by the Panel for Clauses 7.2, 7.3, 7.10 and 9.1.
Appeal Board (18 January 2022): upheld no breach of Clause 7.10; decisions on Clauses 7.2, 7.3 and 9.1 were later set aside due to a procedural error (and had no effect).
Appeal Board (16 June 2022): reconsidered Clauses 7.2, 7.3 and 9.1 afresh and upheld no breach for each.

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