Daiichi Sankyo: Nustendi email found misleading due to implied comparator (AUTH/3772/6/23)

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Key facts

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Case	AUTH/3772/6/23
Company	Daiichi Sankyo UK Ltd
Product	Nustendi (bempedoic acid, ezetimibe)
Material type	Promotional email (sent by a third-party publisher)
Main issue	Headline “38% LDL-C reduction (placebo-corrected)” presented in a “switch from ezetimibe” context, creating a misleading implied comparator
Applicable Code	2021
Complaint received	1 June 2023
Case completed	25 July 2024
Appeal	No appeal
Breach clauses	Clause 5.1; Clause 6.1; Clause 6.2
No breach clauses	Clause 2; Clause 6.1 (x2); Clause 6.2
Sanctions	Undertaking received

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

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A contactable complainant challenged a promotional email for Nustendi (bempedoic acid + ezetimibe) sent via a third-party publisher.
The email prominently urged: “Switch ezetimibe to Nustendi to take back control of elevated LDL-C” and stated Nustendi helps deliver “additional LDL-C reduction without increasing pill burden”.
The email then highlighted: “Nustendi delivered a significant 38% LDL-C reduction (placebo-corrected)…” with a footnote referencing Ballantyne et al (2020).
The complainant alleged the 38% figure was misleading because it was vs placebo (placebo-corrected), not vs ezetimibe, and did not present “absolute numbers”.
Daiichi Sankyo argued the 38% placebo-corrected figure was accurate, referenced, and consistent with the pivotal trial and SmPC wording.
The Panel focused on the overall impression created by the email’s context and layout (switching from ezetimibe) alongside the bold “38%” figure.

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Breach of Clause 5.1 (Failing to maintain high standards).
Breach of Clause 6.1 (Making a misleading claim).
Breach of Clause 6.2 (Making an unsubstantiated claim).
No breach of Clause 2 (Requirement that activities or materials must not bring discredit upon, or reduce confidence in, the pharmaceutical industry).
No breach of Clause 6.1 (x2) (Requirement that claims/information/comparisons must not be misleading) on the additional/narrow grounds considered.
No breach of Clause 6.2 (Requirement that claims/information/comparisons must be capable of substantiation) on the additional/narrow grounds considered.

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