Sobi breached ABPI Code over ‘No anaphylaxis or allergic reactions’ claim in Alprolix BMJ hosted advert

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Key facts

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Case number	AUTH/3345/5/20
Complainant	Health professional (concerned UK health professional)
Company	Swedish Orphan Biovitrum Ltd (Sobi)
Product	Alprolix (eftrenonacog alfa)
Material / channel	BMJ-hosted webpage advertisement (BMJ.com hosted content)
Main issue	Misleading safety headline “No anaphylaxis or allergic reactions” contradicted/qualified by bullets and footnote; insufficient context; inconsistency with SPC
Complaint received	06 May 2020
Case completed	23 September 2020
Applicable Code year	2019
Breach clauses	2, 7.2, 7.4, 7.9, 9.1
Sanctions	Undertaking received; Additional sanctions: Advertisement
Appeal	No appeal
Reach (as stated by company)	393 unique visitors
Live date (as stated by company)	09 January 2020

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

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A UK health professional complained about a Sobi advertisement for Alprolix (eftrenonacog alfa) on a BMJ-hosted webpage.
The section was presented under a tolerability heading referencing clinical studies and long-term data (B-YOND extension study).
A highlighted box carried the bold sub-heading: “No anaphylaxis or allergic reactions”.
Bullets beneath included: (1) “No serious hypersensitivity or anaphylaxis events were reported in clinical studies” and (2) “Hypersensitivity or allergic reactions have been observed rarely in a post-marketing setting and may in some cases progress to severe anaphylaxis (including shock)” (referenced to the SPC).
A linked footnote stated the B-YOND study and parent trial included previously treated patients and safety in previously untreated patients was being investigated.
The complainant alleged the bold heading contradicted the detail, footnotes were effectively hidden on a separate page, and the presentation was misleading with potential patient safety implications.
Sobi took the hosted content down the same day it received the complaint and reviewed/withdrew similar digital materials.

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The Panel found the headline claim “No anaphylaxis or allergic reactions” gave the impression that clinicians need not be concerned about such events.
The Panel considered the claim was contradicted by the bullets and qualified by a footnote, and that insufficient context/explanation was provided.
The Panel noted the presentation appeared to report clinical study results without making this sufficiently clear and that outcomes described were inconsistent with the Alprolix SPC.
Breaches were ruled for misleading and unsubstantiated safety messaging, lack of high standards, and bringing discredit on the industry.
No appeal.

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