Takeda: delayed clinical trial results disclosure for Daxas led to breaches (AUTH/2664/11/13)

📊

Key facts

⌄

Case number	AUTH/2664/11/13
Complainant	Anonymous, contactable member of the public
Company	Takeda
Issue	Clinical trial results disclosure (Mepact, Edarbi and Daxas)
Source prompting complaint	ABPI-funded publication: “Clinical Trial Transparency: an assessment of the disclosure results of company-sponsored trials associated with new medicines approved recently in Europe” (CMRO, 11 November 2013)
Complaint received	18 November 2013 (site listing) / 21 November 2013 (report text)
Case completed	27 March 2014
Applicable Code year (case listing)	2012
Key product with breach	Daxas (roflumilast)
Trials at issue (Daxas)	Four studies not disclosed in timeframe: BY217/M2-012, BY217/M2-013, BY217/M2-121 and BY217/M2-124
Panel finding	Breach of Clause 21.3 and Clause 9.1 (2008 Code) for delayed disclosure; no breach of Clause 2
Other products	Mepact and Edarbi: no breach (no UK involvement for the studies highlighted)
Sanctions	Undertaking received; additional sanctions not stated
Appeal	No appeal

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

📋

⌄

An anonymous, contactable member of the public complained about an ABPI-funded publication on clinical trial transparency (published in Current Medical Research & Opinion, 11 November 2013).
The publication assessed whether results for company-sponsored trials linked to recently approved EMA medicines were disclosed within specified timeframes, using public sources searched 27 December 2012 to 31 January 2013.
The complainant alleged companies (including Takeda) had not disclosed clinical trial results in line with the ABPI Code for licensed products, alleging breaches of Clauses 2, 9 and 21.
Takeda argued (among other points) that earlier Codes focused on disclosure of trial details rather than results, and that some trials/products cited were outside UK Code scope due to no UK involvement.
The Panel assessed three products referenced in the dataset: Mepact (mifamurtide), Edarbi (azilsartan medoxomil) and Daxas (roflumilast), focusing on the studies covered by the publication.
For Daxas, the Panel examined Takeda’s data for 15 completed studies with UK involvement and considered timing against the applicable requirements (2008 Code / Joint Position 2005 for relevant periods).

⚖️

⌄

Mepact: No breach (matter not within scope of the UK Code due to no UK involvement for the studies highlighted).
Edarbi/Azilva-related trials: No breach (no UK involvement; and the two outstanding studies were disclosed within one year of Azilva approval).
Daxas: Breach found for delayed disclosure of four trials completed after 5 January 2005 and before first approval/commercial availability (August 2010), which should have been disclosed by August 2011.
Clause 2: No breach (Panel accepted results had been disclosed by the time of the ruling).
No appeal.

🔒

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