Novo Nordisk v Baxter Healthcare: ‘Up to 85% reduction in bleed frequency’ claim for FEIBA ruled misleading

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Key facts

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Case	AUTH/2400/4/11
Parties	Novo Nordisk Limited v Baxter Healthcare Ltd
Product	FEIBA (Factor VIII Inhibitor Bypassing Activity)
Issue	Promotional claim: “Up to 85% reduction in bleed frequency”
Materials	‘Introducing the FEIBA Prophylaxis Algorithm’ (ADV 09/2758B); ‘FEIBA A systematic treatment approach’ (ADV 09/2815B)
Reference cited	Perry et al (2010)
Complainant’s concern	Cherry-picking a favourable figure from variable results; claim did not reflect evidence clearly
Panel finding	Selection of 85% was misleading; did not reflect all contemporaneous evidence
Breach clauses	Clause 7.2
Applicable Code year	2008
Complaint received	15 April 2011
Case completed	07 June 2011
Appeal	No appeal
Sanctions	Undertaking received

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

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Novo Nordisk complained about Baxter’s promotion of FEIBA (Factor VIII Inhibitor Bypassing Activity).
Two promotional items were challenged: a double-sided single page document, Introducing the FEIBA Prophylaxis Algorithm (ref ADV 09/2758B) and a six-page brochure, FEIBA A systematic treatment approach (ref ADV 09/2815B).
Both featured the efficacy claim: “Up to 85% reduction in bleed frequency”, referenced to Perry et al (2010).
Novo Nordisk argued the claim did not reflect the full evidence base and amounted to cherry-picking from a variable response range (reported as 50–90%).
Novo Nordisk also highlighted that the Perry et al table cited an abstract (Valentino) involving a haemophilia B patient, whereas FEIBA was licensed for haemophilia A patients with inhibitors (and haemophilia B use carried anaphylaxis risk in certain mutations).
Baxter maintained Perry et al substantiated the claim and said it had withdrawn the claim pending revision due to new evidence (not identified), but the Panel assessed the claim as used prior to withdrawal.

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Breach found: the claim “Up to 85% reduction in bleed frequency” was ruled misleading because selecting 85% did not reflect all contemporaneous evidence.
The Panel ruled a breach of Clause 7.2 (Code year 2008).
No appeal.

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