AUTH/3458/1/21: Anonymous health professional v Napp (Invokana) – off-licence promotion allegations dismissed on appeal (no breach) | PMCPA Case

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Key facts

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Case	AUTH/3458/1/21
Parties	Anonymous, contactable health professional v Napp Pharmaceuticals Limited
Product	Invokana (canagliflozin)
Allegation theme	Alleged off-licence promotion; misleading safety/dosing information (renal impairment); competitor misrepresentation
Material	On-demand video “CREDENCE: Type 2 Diabetes Management – A New Perspective. Protect the kidney to protect the heart” (UK/INV-20107ab, Aug 2020) and webpage (UK/INV-20107ac, Sep 2020); pre-roll slide (UK/INV-20107p, Jul 2020)
Applicable Code year	2019
Complaint received	19 January 2021
Case completed	1 October 2021
Final decision	No breach of the Code (appeal successful on all points)
Clauses considered	Clause 2; Clause 3.2; Clause 7.2; Clause 7.9; Clause 9.1
Sanctions	None stated

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

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What happened

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An anonymous, contactable UK health professional complained about Napp’s promotion of Invokana (canagliflozin).
The material was an on-demand promotional video hosted on Diabetes On The Net: “CREDENCE: Type 2 Diabetes Management – A New Perspective. Protect the kidney to protect the heart” (ref UK/INV-20107ab, August 2020) and a linked webpage describing it (ref UK/INV-20107ac, September 2020).
The video discussed results from the CREDENCE trial and was aimed at renal/diabetes/cardiology specialists in secondary care (just over 1 hour; three sessions).
Allegations included:
- Failure to state Invokana is for adults (risk of paediatric/off-licence prescribing).
- Insufficient safety/dosing information for renal impairment, especially given the “protect the kidney to protect the heart” strapline.
- A slide on SGLT2 renal thresholds allegedly misrepresented a competitor (dapagliflozin) due to a footnote.
- Trial outcomes (cardiovascular/renal) presented as reasons to use treatment rather than “added benefits”.
- A slide listing canagliflozin as treatment for cardiovascular disease, kidney disease and diabetes was alleged to be blatant off-licence promotion.
The Panel initially found one brief pre-roll slide (ref UK/INV-20107p, July 2020) misleading because it stated: “For treatment of diabetic kidney disease (DKD) in adults with T2DM as add-on to standard of care, a dose of 100mg once daily should be used. Please see Invokana SmPC section 4.2 for details about dosing”, which the Panel thought implied all DKD patients could be initiated on 100mg regardless of eGFR.
Napp appealed those findings; the Appeal Board considered the slide’s brief display, the audience’s likely caution, the direction to SmPC section 4.2, and later presentation content summarising renal dose adjustments.

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Outcome

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Final outcome (after appeal): No breach of the Code.
The Appeal Board ruled the pre-roll dosing slide did not misleadingly imply all adult T2DM patients with DKD could be given 100mg Invokana in the context of the full video.
All appealed findings were overturned; consequently there was no breach including Clause 2.

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AUTH/3458/1/21: Anonymous health professional v Napp (Invokana) – off-licence promotion allegations dismissed on appeal (no breach)

Key facts

What happened

Outcome

Clauses

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