Daiichi-Sankyo: Lixiana promotional email/video campaign breached Code (missing AE statement, incomplete PI, unsubstantiated ‘proven/ideal’, unlicensed dose reference)

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Key facts

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Case	AUTH/3409/10/20
Company	Daiichi-Sankyo UK Ltd (email signed by Lixiana team at Daiichi-Sankyo Europe)
Medicine	Lixiana (edoxaban)
Therapy area / indication mentioned	Anticoagulant; prevention of stroke and systemic embolism in certain adults with nonvalvular atrial fibrillation (NVAF)
Material	Promotional email and video series (“The Evidence”); Episode 1 titled “The proven choice”; third video included “ideal” claim
Main issues upheld	Missing non-proprietary name adjacent to brand in subject line; missing AE reporting statement; missing date; prescribing information not UK-complete (UK cost missing); unsubstantiated “proven choice” and “ideal” claims; reference to unlicensed “low dose” trial arm without clear qualification; lack of UK certification; high standards and Clause 2
Complaint received	29 October 2020
Case completed	1 April 2021
Applicable Code year	2019
Appeal	No appeal
Sanctions	Undertaking received; Advertisement

Download the full case report (PDF)

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

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What happened

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An anonymous, non-contactable complainant (described as a concerned healthcare professional) complained about a promotional email and video about Lixiana (edoxaban) in NVAF, said to have been sent to one of their patients.
The email subject line was “Lixiana Presents -The Evidence - Series 1 / Episode 1” and promoted a video series; Episode 1 was titled “The proven choice”.
The complainant alleged (among other points) that the material was promotion to the public, lacked required information (PI link/AE statement/date), used unsubstantiated claims (“proven choice”, “ideal”), and included off-label dosing information.
Daiichi-Sankyo submitted the campaign was initiated by Daiichi-Sankyo Europe and run via an external agency without Daiichi-Sankyo UK’s knowledge or UK certification; the campaign used videos originally created in 2018.
The complainant’s hard copy of the email differed from the company’s version; the Panel considered the complete version provided by the company for certain allegations.
The Panel based rulings on the first email and its associated video, and also considered the third video for the “ideal” claim.
Daiichi-Sankyo stated the campaign was intended to target cardiologists and relied on the agency’s health professional verification and opt-in process; the campaign was stopped on 3 September 2020 after a separate inter-company dialogue issue was raised by Bayer.

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Outcome

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No breach was ruled for Clauses 9.9, 9.10, 11.1, 11.3, 12.1, 14.5, 23.1, 23.2, 24.1, 24.2, 26.1, 26.2.
Breach was ruled for Clauses 2, 3.2, 4.1, 4.3, 4.4, 4.5, 4.8, 4.9, 7.2, 7.3, 7.4, 7.10, 9.1, 14.1.
The Panel found the email/video failed key UK requirements (e.g., AE reporting statement, date, and complete prescribing information) and included problematic claims and an unlicensed dose reference.
The Panel ruled Clause 2 (particular censure), noting concerns including missing AE reporting statement and reference to an unlicensed “low-dose” arm.

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Clauses

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Breach: 2
Breach: 3.2
Breach: 4.1
Breach: 4.3
Breach: 4.4
Breach: 4.5
Breach: 4.8
Breach: 4.9
Breach: 7.2
Breach: 7.3
Breach: 7.4
Breach: 7.10
Breach: 9.1
Breach: 14.1
No breach: 9.1
No breach: 9.9
No breach: 9.10
No breach: 11.1
No breach: 11.3
No breach: 12.1
No breach: 14.5
No breach: 23.1
No breach: 23.2
No breach: 24.1
No breach: 24.2
No breach: 26.1
No breach: 26.2

Note: Clause 9.1 appears in both the “No breach” and “Breach” lists in the published case information; the Panel ultimately ruled a breach of Clause 9.1 for failure to maintain high standards in the conduct of the campaign.

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Key facts

What happened

Outcome

Clauses

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