Daiichi Sankyo press release on Nilemdo/Nustendi: combination claim found misleading due to missing simvastatin contraindication (AUTH/3673/7/22)

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Key facts

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Case number	AUTH/3673/7/22
Company	Daiichi Sankyo UK Ltd
Material	Press release for Nilemdo (bempedoic acid) and Nustendi (bempedoic acid/ezetimibe)
Main issue	Nilemdo combination-use statement gave a misleading impression because the simvastatin >40mg daily contraindication was not immediately apparent
Complainant	Anonymous, contactable complainant
Complaint received	01 July 2022
Completed	13 September 2023
Applicable Code year	2021
Appeal	No appeal
Breach clauses	Clause 2; Clause 5.1; Clause 6.1
No breach clauses	Clause 6.1; Clause 6.2
Sanctions	Undertaking received; Advertisement

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

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An anonymous, contactable complainant challenged a Daiichi Sankyo UK press release about Nilemdo (bempedoic acid) and Nustendi (bempedoic acid/ezetimibe).
The press release headline bullet stated: “NILEMDO® … can be combined with other oral treatments to help lower cholesterol even further”.
The complainant alleged this was misleading because Nilemdo is contraindicated with concomitant simvastatin >40mg daily; they also alleged Nustendi had the same contraindication and it was not provided.
The complainant also alleged the NICE recommendation wording was misleading because it omitted that NICE recommended only if supplied according to a commercial arrangement.
Daiichi Sankyo said the press release was aimed at UK journalists (consumer and medical/trade media), focused on the NICE Final Appraisal Document (FAD), had been medically certified, and included links to the SPCs (and additional press-pack materials, including an FAQ covering the commercial arrangement).
The Panel considered the press release on the website to be an exact replica of the company press release and assessed the company-provided information (not any later editorial coverage).

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Breach: The Nilemdo “can be combined with other oral treatments” statement was misleading because the simvastatin >40mg daily contraindication was not immediately apparent in material endorsing combination use; relying on an SPC link was insufficient.
No breach: For Nustendi, the statement did not refer to use with other lipid-lowering treatments; the complainant did not establish why the contraindication needed to be highlighted in that context.
No breach: The complainant did not establish that the NICE FAD recommendation wording used in the press release was misleading due to omission of the commercial arrangement condition (though the Panel noted it might have been helpful to include it).
No breach: Clause 6.2 allegation failed because the complainant did not provide reasons why the press release was incapable of substantiation.
Breach: High standards were not maintained in relation to the misleading Nilemdo combination impression.
Breach: The omission created a risk of inappropriate treatment (patient-safety concern) and was such as to reduce confidence in and bring discredit upon the industry.

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Breach of Clause 6.1 Providing misleading information
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 6.2 Requirement that claims/information/comparisons must be capable of substantiation

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