Bayer v Novartis: Beovu ad claim ‘Outperformed aflibercept’ ruled misleading due to secondary endpoint emphasis (AUTH/3366/7/20)

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Key facts

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Case number	AUTH/3366/7/20
Complainant	Bayer Plc
Respondent	Novartis Pharmaceuticals UK Ltd
Medicine / therapy area	Beovu (brolucizumab) / neovascular (wet) age-related macular degeneration (AMD)
Material	Journal advertisement in Eye News (April 2020), ref BRO20-CO22 (March 2020)
Main claim at issue	“Outperformed aflibercept with superior retinal fluid resolution at Weeks 16 and 48**1”
Comparator	Eylea (aflibercept)
Studies referenced	HAWK and HARRIER (Dugel et al 2020)
Complaint received	17 July 2020
Case completed	17 May 2021
Applicable Code year	2019
Breach(es)	Clause 7.2
No breach	Clauses 7.2 and 7.3 (safety omission allegation not upheld)
Appeal	Appeal by respondent; unsuccessful (Clause 7.2 breach upheld)
Sanctions	Undertaking received; additional sanctions not stated

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

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What happened

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Bayer complained about a Novartis journal advertisement for Beovu (brolucizumab) in Eye News (April 2020), ref BRO20-CO22 (March 2020).
The ad included a prominent headline claim in dark pink: “Outperformed aflibercept with superior retinal fluid resolution at Weeks 16 and 48**”.
The claim was based on HAWK and HARRIER non-inferiority studies (Dugel et al 2020) and relied on retinal fluid resolution data described as a secondary endpoint (with confirmatory analysis in HAWK only).
Context about the primary endpoint (non-inferiority in BCVA change to Week 48) and the secondary nature of the endpoint appeared in small footnote text; the ad did not state that non-inferiority was met.
Bayer also argued the ad failed to reflect an emerging clinical/scientific debate about the clinical relevance of “total retinal fluid” versus fluid in different compartments (e.g., IRF vs SRF).
Bayer further alleged the comparison was misleading by omission because it did not include comparative safety differences; this aspect was considered but not upheld as a breach.

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Outcome

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Breach ruled: Clause 7.2 (twice, on two related grounds) in relation to the headline claim and its context.
Appeal: Novartis appealed the Clause 7.2 ruling on emerging clinical/scientific debate; the Appeal Board upheld the breach and the appeal was unsuccessful.
No breach ruled:</strong Clauses 7.2 and 7.3 in relation to the allegation that comparative efficacy was misleading by omission because comparative safety data were not presented.

Sanctions applied:</strong Undertaking received (per PMCPA case page).

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Key facts

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