AUTH/2836/4/16 AstraZeneca v Janssen: Invokana ‘flexibility’ claim and HbA1c >1% statement

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Key facts

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Case number	AUTH/2836/4/16
Parties	AstraZeneca UK (complainant) v Janssen-Cilag Ltd (respondent)
Product	Invokana (canagliflozin)
Materials	Leavepieces (Oct 2015 PHGB/VOK/0815/0020; Jan 2016 PHGB/VOK/0815/0020(1)); Journal advertisement (Sep 2015 PHGB/VOC/0815/0018)
Main issues	“Flexibility” headline implying 300mg could be a starting dose; accuracy of HbA1c “greater than 1% across four trials” claim; use of studies initiating 300mg to support 300mg claims; comparisons vs sitagliptin
Breach clauses	3.2; 7.2; 7.4
No breach clauses	2; 7.2; 7.3; 7.4; 9.1
Sanctions	Undertaking received; Additional sanctions: Not stated
Complaint received	11 April 2016
Case completed	21 July 2016
Appeal	Appeal by complainant (unsuccessful)
Applicable Code year	2016

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

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AstraZeneca UK complained about Janssen-Cilag promotional materials for Invokana (canagliflozin): two leavepieces (Oct 2015 PHGB/VOK/0815/0020; Jan 2016 PHGB/VOK/0815/0020(1)) and a journal advertisement (Sep 2015 PHGB/VOC/0815/0018).
Headline claim used in the Oct 2015 leavepiece and Sep 2015 ad: “Invokana 100mg and 300mg efficacy and flexibility* at a single price”, with the recommended starting dose (100mg) only explained in a small footnote.
Materials included comparative claims vs sitagliptin and efficacy claims for 100mg and 300mg, supported by published studies and/or SPC references.
A key efficacy superlative stated: “The only SGLT2i to offer reductions in HbA1c greater than 1% across four clinical trials” (supported by four cited trials).
AstraZeneca argued that several 300mg claims were misleading because pivotal studies initiated patients on 300mg, whereas the SPC recommended starting at 100mg and increasing to 300mg only in appropriate patients.

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Breach found for the use of the word “flexibility” in the headline claim: it was misleading and inconsistent with the SPC because it did not make clear where each dose fitted in the treatment pathway and could be read as relating to the starting dose.
Breach found for an efficacy claim on HbA1c: the statement that HbA1c reductions were “greater than 1% across four clinical trials” was incorrect (one cited study reported 0.96% at week 52).
No breach for the broader allegation that citing studies initiating 300mg was necessarily inconsistent with the SPC (on the narrow grounds of the complaint), and no breach for the comparative claims vs sitagliptin on that basis.
No breach of Clause 2 (discredit/industry confidence) and no breach of Clause 9.1 (high standards) were ruled; these were upheld on appeal.
Appeals by AstraZeneca were unsuccessful; Janssen accepted the Panel’s breaches for Clauses 3.2 and 7.2 relating to “flexibility”.

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