AUTH/3250/10/19: Lilly/Director v Janssen – Tremfya (guselkumab) and psoriatic arthritis ‘pipeline’ session ruled promotional (breach of undertaking) | PMCPA Case

📊

Key facts

⌄

Case	AUTH/3250/10/19
Parties	Eli Lilly & Company / Director v Janssen-Cilag
Product	Tremfya (guselkumab)
Therapy area / topic	Psoriatic arthritis (PsA) pipeline session
Event	“Pipelines in Psoriatic Arthritis” at BSR Annual Conference (innovation theatre session)
Date of event	1 May 2019
Complaint received	04 October 2019
Completed	03 August 2020
Appeal	No appeal
Applicable Code year	2019
Breach clauses	2; 3.2; 9.1; 29
Sanctions	Undertaking received; Additional sanctions: Advertisement
Notable practical factors cited	Open-plan theatre in exhibition hall; 63 slides in 20 minutes; limited discussion (two main questions); conclusion/summary wording considered promotional

Download the full case report (PDF)

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

🤖

Got a question about this case?

Ask one of our 13 specialist ABPI advisors — instant answers, 24/7.

Ask AskAnzal AI

🎬 Expert Video Walkthrough

🎬

Video walkthrough — coming for members

Subscribe now and get expert video analysis for every case as we publish them.

Subscribe — from £299/yr

📋

What happened

⌄

Eli Lilly complained that Janssen-Cilag promoted Tremfya (guselkumab) for psoriatic arthritis (PsA) at a Janssen-sponsored session (“Pipelines in Psoriatic Arthritis”) at the British Society of Rheumatology (BSR) Annual Conference (1 May 2019).
At the time, Tremfya was licensed for moderate to severe plaque psoriasis in adults who were candidates for systemic therapy, but not licensed for PsA; Phase III studies were ongoing.
The session was held in an “open plan” innovation theatre within the exhibition hall (a non-segregated area near exhibition stands) with slides projected on a large screen potentially visible to non-attendees.
The session format was 40 minutes total: 5-minute introduction, 20-minute presentation, 15-minute Q&A/discussion; 63 slides were presented and only two main questions were discussed at the end.
The presentation included guselkumab among seven compounds in development for PsA; a guselkumab slide contained a “Conclusions” box with efficacy-style statements (eg “robust efficacy… maintained through Week 56” and “rapid and sustained improvement in enthesitis…”).
A summary slide stated, among other points, “Novel treatments have demonstrated favourable efficacy and safety profiles in placebo-controlled trials,” which the Panel considered referred to all potential PsA treatments including guselkumab.
An evaluation form invited attendees to request “further information on the topics discussed,” which the Panel considered could be seen as soliciting interest/questions about unlicensed use.
Because the complaint included an alleged breach of an earlier undertaking (from Case AUTH/2978/9/17), the Director took up that part of the complaint.

⚖️

Outcome

⌄

The Panel ruled that, on balance, the meeting was not the legitimate exchange of medical and scientific information.
The Panel ruled that the meeting discussed guselkumab for PsA and promoted it for an unlicensed indication.
Breaches were ruled of Clause 3.2 (promotion of an unlicensed indication), Clause 9.1 (high standards), Clause 2 (bringing discredit upon/reducing confidence in the industry), and Clause 29 (breach of undertaking).
No appeal: No appeal stated on the case page.

🔒

Unlock the full case analysis

Members get the complete breakdown — Clauses, Sanction, Signatory Lens, Audit checklist, and 3 Key Questions.

Best value

£249/year

Annual — save £99

£29/mo

Monthly

Join Now — Instant Access

AUTH/3250/10/19: Lilly/Director v Janssen – Tremfya (guselkumab) and psoriatic arthritis ‘pipeline’ session ruled promotional (breach of undertaking)

Key facts

What happened

Outcome

Clauses

Unlock the full case analysis

AQP Flagship Path — the complete UK ABPI signatory programme

📰 Weekly PMCPA Case Breakdown