AUTH/3673/7/22 - Complainant v Daiichi Sankyo

Allegations about a press release for Nilemdo and Nustendi

  • Received
    01 July 2022
  • Case number
  • Applicable Code year
  • Completed
    13 September 2023
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal

Case Summary


This case was in relation to a press release for Nilemdo (bempedoic acid) and Nustendi (bempedoic acid and ezetimibe) by Daiichi Sankyo UK Ltd.

The Panel ruled a breach of the following Clauses of the 2021 Code because the contraindication with simvastatin >40mg daily was not immediately apparent when reference to therapeutic use of Nilemdo with oral treatments to lower cholesterol was referred to, which was misleading.  This might prejudice patient safety and was such as to reduce confidence in, and bring discredit upon, the pharmaceutical industry: 

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

The Panel ruled no breach of the following Clauses of the 2021 Code because: 

  • the statement with regard to Nustendi, unlike with Nilemdo, did not refer to its use with other lipid-lowering treatments and the complainant had not established why the contraindication was required
  • it did not consider that the complainant had established that the information that NICE had ‘issued a Final Appraisal Document (FAD) recommending bempedoic acid and bempedoic acid / ezetimibe for treating primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia as an adjunct to diet, only if statins are contraindicated or not tolerated, and ezetimibe alone does not control low-density lipoprotein cholesterol well enough, on the NHS in England’ was misleading as alleged
  • the complainant had not provided reasons as to why, in their view, the press release was incapable of substantiation.

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 

This summary is not intended to be read in isolation.
             For full details, please see the full case report below.