Wyeth v Lilly & Boehringer Ingelheim: Cymbalta detail aid implied equivalent efficacy vs venlafaxine without proof (AUTH/2061/10/07, AUTH/2062/10/07)

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Key facts

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Case numbers	AUTH/2061/10/07 and AUTH/2062/10/07
Parties	Wyeth v Lilly and Boehringer Ingelheim
Product	Cymbalta (duloxetine)
Comparator mentioned	Venlafaxine XL (Efexor XL)
Material	Primary care detail aid (CYM 1072); earlier CYM 1008 withdrawn and not ruled upon
Main issue	Implied equivalent efficacy based on Perahia et al (2007) despite lack of proof of equivalence/non-inferiority
Applicable Code year	2006
Complaint received	24 October 2007
Case completed	03 December 2007
Appeal	No appeal
Breach clauses	7.2, 7.3, 7.4 and 7.8
Sanctions	Undertaking received; additional sanctions not stated

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

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Wyeth complained about comparative efficacy claims in a primary care detail aid for Cymbalta (duloxetine) issued by Lilly and Boehringer Ingelheim (the Alliance), comparing it with venlafaxine XL (Efexor XL).
The original claim in an earlier detail aid (CYM 1008) was: “Cymbalta vs venlafaxine XL – Cymbalta 60mg OD had similar efficacy to venlafaxine XL 150mg OD”, referenced to Perahia et al (2007).
Perahia et al included a non-inferiority analysis which was negative; the authors stated duloxetine 60mg/day failed to meet the a priori non-inferiority criteria vs venlafaxine 150mg/day at certain study periods.
After inter-company discussions, CYM 1008 and other sales material were withdrawn; the Panel did not rule on CYM 1008.
The complaint proceeded on the updated detail aid (CYM 1072) which stated: “In this study, the efficacy of Cymbalta 60mg OD has not been shown to be different from venlafaxine 150mg XL OD … – secondary endpoint” and included a graph with near-superimposed lines plus the bullet: “With no direct evidence of difference in efficacy to venlafaxine XL 150mg OD”.
The Panel considered Perahia et al a useful first head-to-head comparison but noted study limitations and that more studies were needed; it had not proven equivalence.

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The Panel ruled the CYM 1072 detail aid implied, beyond doubt, equivalent efficacy between Cymbalta and venlafaxine, which was not established.
The material was found misleading and the claim could not be substantiated.
Breach rulings were made under Clauses 7.2, 7.3, 7.4 and 7.8.
No appeal.

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