Daiichi Sankyo: Nilemdo/Nustendi “add-on” materials didn’t make simvastatin >40mg contraindication immediately apparent (AUTH/3677/7/22)

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Key facts

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Case	AUTH/3677/7/22
Company	Daiichi Sankyo
Products	Nilemdo (bempedoic acid); Nustendi (bempedoic acid and ezetimibe)
Main issue	“Add-on” promotional messaging did not make the contraindication with simvastatin >40mg immediately apparent on key slides/pages; briefing materials did not sufficiently reinforce the need to mention it whenever discussing combination with statins/LLTs.
Materials in scope (examples)	Sales aids: BEM/21/0826 (short), BEM/21/0828 (long); Briefing docs: BEM/21/0827, BEM/21/0829; Leavepieces: BEM/21/0653, BEM/21/0816
Time period referenced	April 2021–February 2022 (use of materials during sales calls, per complaint)
Complaint received	07 July 2022
Case completed	25 October 2023
Applicable Code	2021
Breach clauses	2; 5.1; 6.1; 6.2
No breach clauses	6.1; 17.1
Sanctions	Undertaking received; Advertisement
Appeal	No appeal

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

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An anonymous, contactable health professional complained about promotion of Nilemdo (bempedoic acid) and Nustendi (bempedoic acid/ezetimibe).
Concern: representatives used sales aids and hard-copy leavepieces (used during April 2021–February 2022) that discussed adding Nilemdo/Nustendi to statins/other lipid-lowering therapies (LLTs) but did not make clear the contraindication with simvastatin doses >40mg.
Concern also covered whether representatives were properly trained/briefed to mention the contraindication whenever discussing combination with statins/LLTs.
The Panel assessed the materials provided by the company for the relevant period, including sales aids (refs BEM/21/0826 and BEM/21/0828), leavepieces (refs BEM/21/0653 and BEM/21/0816) and briefing documents (refs BEM/21/0827 and BEM/21/0829).
The Panel emphasised an established principle: companies cannot rely on footnotes or prescribing information to negate a misleading impression; and in modular/digital materials, each slide/page must stand alone.

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Breach found: sales aids and leavepieces were misleading because slides/pages promoting “add-on” use with statins/LLTs did not make the simvastatin >40mg contraindication immediately apparent.
Breach found: the misleading impression (that products could be used with any dose of any statin/simvastatin) was unsubstantiated.
Breach found: briefing documents did not make it sufficiently clear that the contraindication must be mentioned whenever discussing combination with statins/LLTs; therefore reps were not given clear briefing on this point.
Breach found: multiple materials had the same issue; the Panel considered the repeated failure particularly serious, with potential to prejudice patient safety and bring discredit on the industry.
No breach found (narrow grounds): it was not established that representatives failed to mention the contraindication during specific sales calls (complainant provided no specific call details).
No breach found: it was not established that representatives had not been trained properly on mandatory contraindications (the allegation related to general training activities; evidence did not establish inadequate training).

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Breach of Clause 6.1 Making a misleading claim
Breach of Clause 6.2 Making an unsubstantiated claim
Breach of Clause 5.1 Failing to maintain high standards
Breach of Clause 2 Bringing discredit upon, and reducing confidence in, the pharmaceutical industry
No Breach of Clause 6.1 Requirement that claims/information/comparisons must not be misleading
No Breach of Clause 17.1 Requirement that representatives must be given adequate training and have sufficient scientific knowledge to enable them to provide full and accurate information about the medicines which they promote

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