AUTH/3632/4/22: Daiichi Sankyo – Lixiana (edoxaban) initiation video on learned society site (No breach) | PMCPA Case

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Key facts

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Case	AUTH/3632/4/22
Company	Daiichi Sankyo
Product	Lixiana (edoxaban)
Material type	Promotional/educational video(s) intended for a learned society website (staging site)
Main allegation	Omission of hepatic function monitoring/contraindications from initiation content; question over certification; verbal error re inducer vs inhibitor
Applicable Code year	2021
Clauses considered	2, 5.1, 6.1, 6.2, 8.1
Outcome	No breach of Clauses 2, 5.1, 6.1, 6.2, 8.1
Panel rationale (in brief)	On the evidence available, material was draft content on an unlisted staging site and had not been made available to health professionals
Complaint received	11 April 2022
Case completed	3 April 2023
Appeal	No appeal

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

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A cardiac expert complained about what was described as a webinar/video on initiating Lixiana (edoxaban) hosted on a learned society webpage.
The complainant alleged the video focused on renal function but omitted hepatic function testing/contraindications said to be required per the edoxaban SPC.
The complainant also questioned whether the video (vs slides only) had been certified, and alleged the speaker said dose reduction was needed with “inducers” (complainant said it should be “inhibitors”).
Daiichi Sankyo said it was not a live webinar; it was draft “talking head” educational content intended for a password-protected HCP area, hosted on an unlisted staging site for testing/review.
Daiichi Sankyo said the inducer/inhibitor verbal error had already been identified and corrected during review, before the complaint.
The Panel noted the complainant provided no evidence showing the staging page was accessible via publicly available webpages, and on the balance of probabilities it was an unlisted staging site not accessed by external HCPs.

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No breach of the ABPI Code of Practice (2021).
The Panel queried that hepatic considerations might be relevant to include in the body of material about initiating edoxaban, but ruled no breach because the material was draft and had not been made available to health professionals.
No appeal.

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No Breach of Clause 2 Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
No Breach of Clause 5.1 Requirement to maintain high standards
No Breach of Clause 6.1 Requirement that information must be accurate, up-to-date and not misleading
No Breach of Clause 6.2 Requirement that claims/information/comparisons must be capable of substantiation
No Breach of Clause 8.1 Requirement to certify promotional material

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