AUTH/3391/9/20 - Complainant v Sanofi

Promotion of Praluent

  • Received
    30 September 2020
  • Case number
    AUTH/3391/9/20
  • Applicable Code year
    2019
  • Completed
    22 February 2021
  • No breach Clause(s)
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

A complainant, who described him/herself as a concerned UK health professional, complained about a banner advertisement which appeared on the Praluent (alirocumab) website owned by Sanofi. Praluent was a lipid lowering agent for use in certain adults with either primary hypercholesterolaemia or mixed dyslipidaemia and in certain adults with established atherosclerotic cardiovascular disease.

The banner advertisement provided by the complainant showed a picture of some runners with a man leading the group. The headline read ‘He survived a CV [cardiovascular] event, now reduce his CV risk further* with Praluent’.

The complainant referred to the licensed indication for Praluent and alleged that the headline (‘He survived a CV event, now reduce his CV risk further* with Praluent’) did not make it at all clear that the indication was very particular and specifically that Praluent was an adjunct to other agents or for those who were intolerant of other therapies (even if the reader noticed the smaller text below which mentioned the patient was not at LDL-C goal). The complainant alleged that the advertisement would encompass considerably more patients than the licence, and therefore was off-licence promotion.

The complainant stated that the licensed indication might be mentioned much further down the web page, but the headline as it stood was misleading and should not require other parts of the web page to be factually correct.

The detailed response from Sanofi is given below.

The Panel noted Sanofi’s submission that the claim at issue ‘He survived a CV [cardiovascular] event, now reduce his CV risk further* with Praluent’, was clearly referring to secondary prevention. The banner advertisement referred to an individual having had an MI (myocardial infarction) 6 months ago who was not at LDL-C goal. It appeared to the Panel that Sanofi was only referring to one aspect of the Praulent indication in the SPC in relation to established artherosclerotic cardiovascular disease.

The Panel noted Sanofi’s submission that it was standard clinical practice to manage patients having had any acute coronary event (including an MI) with statins initially to reduce their LDL-C levels and any patient who had had an MI six months previously and was still not at LDL-C goal would, by definition (having received standard recommended care), fall into one of the following three categories: Started on statin and titrated to maximal tolerated dose after 3 months; unable to tolerate statins, but might or might not be on other lipid lowering agents; or had a contraindication to statins but might or might not be on other lipid lowering agents - all of which Sanofi submitted were within the licensed indication.

The Panel further noted Sanofi’s submission that the second part of the claim at issue, ‘… now reduce his CV risk further with Praluent’ made it clear that steps to manage cardiovascular risk factors had already been taken following the CV event, as would be usual clinical practice.

The full wording of the relevant licensed indication in the Praluent SPC was included on the webpage in a prominent box near the banner advertisement and below the navigation buttons. The Panel noted the layout of the webpage and considered that health professionals would not be misled as to the licensed indication for Praluent in established artherosclerotic cardiovascular disease. The Panel did not consider that the claim at issue was inconsistent with the Praluent SPC nor had Sanofi failed to maintain high standards. No breaches of the Code were ruled.