AUTH/3582/11/21: AbbVie v Galapagos — Jyseleca website claims (safety ‘low rates’ and ‘sustained efficacy’ summary)

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Key facts

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Case	AUTH/3582/11/21
Parties	AbbVie Ltd v Galapagos Biotech Ltd
Product / context	Jyseleca (filgotinib) promotional website for rheumatoid arthritis (RA)
Channel	Promotional website for health professionals (UK and Ireland)
Materials/pages	Safety page UK-INF-2020-11-0063; At a glance page UK-INF-2020-11-0066 (both March 2021; last accessed 15 Nov 2021)
Main breach themes	Misleading/ambiguous safety headline (“low rates”) and incomplete/misleading efficacy summary page; high standards not maintained
Breach clauses	5.1; 6.1; 6.2
No breach clauses	2; 6.1; 6.2; 6.4
Sanctions	Undertaking received
Complaint received	15 November 2021
Case completed	09 January 2023
Appeal	No appeal
Applicable Code year	2021

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

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AbbVie complained about promotional claims on Galapagos’ UK/Ireland HCP website strengthofbalance.co.uk for Jyseleca (filgotinib) in rheumatoid arthritis.
The complaint focused on two webpages/materials: the Safety page (UK-INF-2020-11-0063; March 2021; last accessed 15 Nov 2021) and the At a glance summary page (UK-INF-2020-11-0066; March 2021; last accessed 15 Nov 2021).
Key disputed safety claim: “Treatment with JYSELECA was associated with consistently low rates* of JAK inhibitor-associated adverse events up to 52 weeks”, where the qualifying definition of “low” appeared in small-print footnotes and the table included some higher rates.
Key disputed efficacy area: an “SUSTAINED EFFICACY” bullet list (eg ACR responses, DAS28-CRP remission, and radiographic progression vs adalimumab) that AbbVie said lacked context (dose, comparator clarity, and statistical context).
AbbVie also alleged broader concerns about safety balance and asked the PMCPA to consider Clause 2 (discredit to the industry), citing patient-safety focus and alleged failures in inter-company dialogue timelines.

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No ruling on the general “safety page as a whole” concerns (Point 1.1) because the Panel considered that matter had been settled during inter-company dialogue at the time the complaint was submitted.
Breach for the safety claim “consistently low rates” being misleading/ambiguous and incapable of substantiation in context (Point 1.2).
No breach for the claim “Similar observed rates of serious infections, herpes zoster and VTE compared to adalimumab” on the narrow issue of substantiation raised (Point 1.3).
Breach of high standards for the safety page overall in light of the Point 1.2 issue (Point 1.4).
Breach for the At a glance sustained efficacy summary being incomplete and misleading such that readers did not have sufficient information to form their own view of therapeutic value; and breach of high standards (Point 2).
No breach of Clause 2.

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