AUTH/3459/1/21: Complainant v Napp — Invokana webcast advertisement (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/3459/1/21
Company	Napp Pharmaceuticals Limited
Complainant	Contactable complainant (concerned UK health professional)
Product	Invokana (canagliflozin), SGLT2 inhibitor
Material	Advertisement/registration webpage for a forthcoming promotional webcast on Diabetes On The Net (ref UK-INV-2000106, January 2021)
Main allegations	Off-licence renoprotection promotion; missing renal dosing/eGFR initiation limitation; missing adult-only statement; unclear/unsupported “licence extension” reference
Panel note	Complaint submitted before webcast aired; webcast itself not considered
Applicable Code year	2019
Clauses considered	2, 3.2, 7.2, 7.9, 9.1
Outcome	No breach
Complaint received	19 January 2021
Case completed	19 July 2021
Appeal	No appeal

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

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A UK health professional complained about an advertisement for a forthcoming promotional Invokana (canagliflozin) webcast hosted on Diabetes On The Net (ref UK-INV-2000106, January 2021).
The webcast title was “SGLT2 inhibitors: Slowing of chronic kidney disease progression in type 2 diabetes”, with an agenda including a session on “Renoprotective effects of SGLT2 inhibitors: Evidence and mechanisms”.
The complainant alleged off-licence promotion, saying Invokana had no licensed reno-protective indication and referenced a slogan (“protect the kidney to protect the heart”).
The complainant alleged missing safety/renal dosing information (including that Invokana should not be started in patients with eGFR under 30) and raised patient safety concerns.
The complainant alleged the page did not state Invokana was for adults only (implying potential off-licence promotion).
The complainant challenged an agenda item referring to “Invokana licence extension as a result of CREDENCE”, stating they could not find evidence of a licence extension on the prescribing information, eMC or EMA website.
The complaint was submitted before the webcast was shown; the Panel did not consider the webcast itself—only the webpage advertising it.

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No breach of the Code was ruled.
The Panel found the webpage’s references to renal benefits were set within the context of treating type 2 diabetes and were consistent with the SPC/marketing authorisation.
The Panel accepted that the alleged slogan (“protect the kidney to protect the heart”) did not appear in the advertisement or related materials.
The Panel found prescribing information was available via a prominent link/button on the webpage and included renal impairment dosing recommendations and the adult indication.
The Panel did not consider the webpage misleading regarding renal dosing, adult-only use, or the “licence extension” reference.

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