Leo voluntary admission: uncertified Kyntheum website pages (AUTH/3647/5/22)

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Key facts

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Case number	AUTH/3647/5/22
Company	Leo
Type	Voluntary admission
Issue	Uncertified promotional material on UK promotional website pages
Product	Kyntheum (brodalumab)
Material/channel	Promotional website (Dermaworld) – ‘At a glance’ and ‘Mode of action’ webpages
Key job codes/pages	At a glance tab: MAT-21384 May 2019; Mode of action tab: MAT-39266 Nov 2020 (global-approved uploaded to UK site)
Applicable Code	2019
Complaint received	13 May 2022
Case completed	4 May 2023
Panel findings	Breach Clauses 14.1 and 9.1; No breach Clause 2
Appeal	No appeal
Sanctions	Undertaking received; additional sanctions not stated

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

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Leo made a voluntary admission about uncertified promotional material on the Kyntheum (brodalumab) promotional website (Dermaworld).
Issue identified during Leo’s investigation connected to an earlier complaint/case (AUTH/3503/4/21) and subsequent PMCPA requests for further information.
Two UK webpages were at issue:
- ‘At a glance’ tab (MAT-21384 May 2019): the live page differed from the certified version, including an out-of-date SPC reference (September 2017) instead of the correct SPC reference (last accessed March 2020).
- ‘Mode of action’ tab (MAT-39266 Nov 2020): material approved for the global website (not the UK) was uploaded to the UK site by a third-party agency, meaning the UK site displayed material that had not been UK-certified.
Leo initially included the home tab in its voluntary admission but later withdrew that element; the Panel made no ruling on the home tab.
Leo stated the errors arose from third-party agency uploading mistakes; the Panel focused on Leo’s control and governance over promotional material.

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Breach of Clause 14.1 (for each of the two webpages): failing to certify promotional material as required by the Code.
Breach of Clause 9.1: failing to maintain high standards (Panel concern that Leo did not have adequate control over promotional materials; certification underpins self-regulation).
No breach of Clause 2: the Panel considered the uncertified-material issue was adequately covered by the rulings under Clauses 14.1 and 9.1, and content allegations were addressed in the earlier case (AUTH/3503/4/21).
No ruling made on the home tab because Leo withdrew that part of the voluntary admission.

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Breach of Clause 14.1 Failing to certify promotional material as required by the Code
Breach of Clause 9.1 Failing to maintain high standards
No Breach of Clause 2 Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry

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