Sanofi: Dupixent website materials used outdated prescribing information and a misleading asthma statement (AUTH/3402/10/20)

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Key facts

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Case	AUTH/3402/10/20
Company	Sanofi
Medicine	Dupixent (dupilumab)
Channel	Product website (dupixent.co.uk) downloadable resources
Main issues	Out-of-date prescribing information (Oct 2017 used instead of July 2020); misleading statement that asthma safety/efficacy not established
Complainant	Health professional (self-described)
Complaint received	21 October 2020
Case completed	29 March 2021
Applicable Code year	2019
Breach clauses	Clause 2; Clause 3.2; Clause 7.2; Clause 9.1
No breach	Clause 2 (for the HCP guide aspect)
Sanctions	Undertaking received; Advertisement
Appeal	No appeal

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

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A health professional complained that material on Sanofi’s Dupixent (dupilumab) product website (dupixent.co.uk) was inaccurate.
Two downloadable resources were highlighted:
- A document referring to NICE Technology Appraisal Guidance TA534 that included prescribing information dated October 2017 (out of date vs current July 2020 prescribing information).
- An HCP guide (MAT-GB-2001250 v1.0) for atopic dermatitis that stated under “Comorbid Asthma”: “Safety and efficacy of Dupixent have not been established in the treatment of asthma”.
The Panel noted the SPC included a specific asthma indication (add-on maintenance treatment for severe asthma with type 2 inflammation in patients aged 12+ meeting criteria) and discussed asthma efficacy/safety in section 5.1.
Sanofi explained the outdated NICE resource persisted during a system transition (Zinc to Veeva PromoMats) and was not noticed as uncertified/approved when the webpage was certified.

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The HCP guide statement that asthma safety/efficacy had not been established was ruled misleading and inconsistent with the SPC.
The NICE TA534 resource was ruled to contain out-of-date prescribing information.
Clause 2 was ruled for the out-of-date prescribing information failures (bringing discredit/reducing confidence in the industry).
No breach of Clause 2 was ruled in relation to the misleading statement in the HCP guide (the Panel did not consider it warranted Clause 2 in those circumstances).
No appeal.

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