Daiichi-Sankyo: Nilemdo/Nustendi HCP website claims and readability of generic names (AUTH/3504/4/21)

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Key facts

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Case	AUTH/3504/4/21
Company	Daiichi-Sankyo UK Ltd
Products	Nilemdo (bempedoic acid); Nustendi (bempedoic acid, ezetimibe)
Channel/material	HCP website webpages (https://www.nilemdo-nustendi.co.uk/hcp/); Job Code BEM/20/0242; Date of preparation October 2020
Indication context (as stated)	Adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet
Main upheld issues	Generic name not readily readable (Clause 4.3); misleading “add to existing oral lipid-lowering treatments” type claims where contraindications were not immediately apparent and claims could not stand alone (Clauses 7.2, 7.4); high standards (Clause 9.1); patient safety concern (Clause 2)
Sanctions	Undertaking received; Additional sanctions: Advertisement
Complaint received	17 April 2021
Case completed	6 December 2021
Applicable Code year	2019
Appeal	No appeal

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

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A complainant (later non-contactable) raised concerns about compliance failings and patient safety risks on multiple webpages promoting Nilemdo (bempedoic acid) and Nustendi (bempedoic acid/ezetimibe) on an HCP website (Job Code BEM/20/0242; prepared October 2020).
The complainant alleged the non-proprietary (generic) names were too small on the homepage and across the site, and that prominent claims implied overly broad use (eg, “added to existing oral lipid lowering treatments”).
Key safety limitations (notably contraindication with concomitant simvastatin >40mg daily; and for Nustendi with a statin in active liver disease/unexplained persistent transaminase elevations) were presented via footnotes or not made immediately apparent next to the claims.
Additional allegations (eg, “add on to take back control” being misleading; adult-only implication; LDL-C % reductions needing absolute risk; mobile PI access/certification) were considered but not upheld.

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Breach found: Clause 4.3 (generic name not readily readable on evidence before the Panel).
Breach found: Clauses 7.2 and 7.4 for claims implying Nilemdo/Nustendi could be added to any existing oral lipid-lowering treatments, where contraindications (eg, simvastatin >40mg daily) needed to be immediately apparent and the claims could not stand alone.
Breach found: Clause 9.1 (failure to maintain high standards) linked to the misleading impressions created by the claims.
Breach found: Clause 2 (potential to prejudice patient safety) in relation to the misleading “add to existing oral lipid-lowering treatments” claim(s), particularly regarding patients taking simvastatin >40mg daily.
No breach (selected): Clauses 7.2/7.3/7.4/9.1/2 for the strapline “add on to take back control”; Clauses 3.2/7.2/7.4/9.1/2 for “patients” wording (adult indication was stated); Clause 7.2 for LDL-C % reduction claims; Clause 14.1 (mobile version certification/PI access allegation not established).

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