Advert Daiichi Sankyo – Case AUTH/3677/7/22

In referring to the therapeutic use of Nilemdo (bempedoic acid) and Nustendi (bempedoic acid and ezetimibe) in combination with a statin/other lipid lowering therapies, without sufficiently mentioning that they were contraindicated with simvastatin>40mg in two sales aids, two leavepieces and two briefing materials for representatives, particularly given that simvastatin was a commonly prescribed statin, meant that there was a risk that some patients on simvastatin >40mg daily might be inappropriately treated with Nilemdo or Nustendi and for the repeated failure to comply with the Code on this matter which was particularly serious and might prejudice patient safety Daiichi Sankyo was ruled in breach of the following clauses of the 2021 Code:

Clause 2 - Bringing discredit upon, and reducing confidence in, the pharmaceutical industry
Clause 5.1 - Failing to maintain high standards
Clause 6.1 - Misleading impression provided
Clause 6.2 - Misleading impression incapable of substantiation