AUTH/3460/1/21: Complainant v Novartis — Beovu journal ad and safety information (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/3460/1/21
Company	Novartis Pharmaceuticals UK
Product	Beovu (brolucizumab)
Therapy area	Neovascular (wet) age-related macular degeneration (nAMD)
Material	Journal advertisement in the British Journal of Ophthalmology (December 2020 issue); ref BRO20 – C053 (November 2020)
Main allegation	Lack of safety information in the ad body given serious sight-threatening complications / SPC update; alleged misleading and patient safety risk
Applicable Code year	2019
Clauses considered	2, 7.2, 7.10, 9.1
Panel decision	No breach of the Code
Complaint received	21 January 2021
Case completed	24 August 2021
Appeal	No appeal
Notes on safety info in ad	Prescribing information included warnings/precautions and undesirable effects for retinal vasculitis and/or retinal vascular occlusion (frequency “not known”)

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

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A complainant (described themself as a health professional) challenged a Novartis Pharmaceuticals UK journal advertisement for Beovu (brolucizumab) placed in the December 2020 issue of the British Journal of Ophthalmology (ref BRO20 – C053, November 2020).
The ad was headed “For adults with wet AMD, their vision is a masterpiece” and included four claims attributed to the HAWK and HARRIER trials (three efficacy claims and one safety claim: “In HAWK & HARRIER, Beovu Exhibited an overall well-tolerated safety profile in treated patients”).
The complainant’s concern was the lack of safety information in the body of the ad, given serious sight-threatening complications and an SPC update; they argued this was irresponsible, misleading and risked patient safety.
Novartis responded that retinal vasculitis/retinal vascular occlusion were first seen in post-marketing reports (not the pivotal trials), that the SPC had been updated (EMA approval 15 October 2020), and that the ad’s prescribing information included the relevant warnings and undesirable effects (frequency “not known”).
The Panel considered the specialist context (intravitreal injection administered by qualified ophthalmologists) and assessed whether omission of additional safety detail in the ad body was misleading given the prescribing information included in the ad.

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No breach of the Code was ruled.
No breach of Clause 7.2 (sufficiently complete / not misleading by omission) was ruled.
No breach of Clause 7.10 (rational use / not misleading) was ruled.
No breach of Clause 9.1 (high standards) was ruled.
No breach of Clause 2 was ruled.
The Panel noted the reference to www.brolucizumab.info but made no ruling as it was not the subject of the complaint.

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