AstraZeneca breached the Code over incomplete Symbicort dosing and missing prescribing information/non-proprietary names on Trixeo site (AUTH/3585/11/21)

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Key facts

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Case	AUTH/3585/11/21
Company	AstraZeneca
Complainant	Anonymous, contactable; described themselves as a health professional
Medicines	Symbicort turbohaler (budesonide/formoterol), Trixeo (formoterol/budesonide/glycopyrronium), Bevespi (glycopyrronium/formoterol), Daxas (roflumilast), Eklira (aclidinium bromide)
Materials	Symbicort devices webpage (GB-31536 Oct 2021); Trixeo digital ad (GB-30263 Aug 2021); Trixeo HCP website pages (GB-29626 DOP June 2021) incl. home/efficacy/safety/dosing/learn-more and a “Breaking Boundaries in COPD” video
Applicable Code	2021
Complaint received	27 November 2021
Case completed	18 January 2023
Appeal	No appeal
Breach clauses	2, 5.1, 6.1, 6.2, 12.1, 12.3, 12.4, 12.6
No breach clauses (in parts)	6.1, 6.2, 5.1, 2 (for the Trixeo digital ad and certain other allegations); 2 (overall circumstances)
Sanctions	Undertaking received; additional sanctions: Not stated

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

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An anonymous, contactable health professional complained about AstraZeneca respiratory promotional content across multiple webpages and a digital ad (Code year 2021).
Symbicort webpage (GB-31536, Oct 2021): dosing stated “Two inhalations in the morning, two inhalations in the evening and two inhalations as needed” for Symbicort pMDI 100/3, without stating an upper limit or the SPC’s strong recommendation to seek medical advice if using >16 actuations daily.
Trixeo digital ad (GB-30263, Aug 2021): claim “TRIPLE PROTECTION… from exacerbations, hospitalisations and symptoms” was alleged to be misleading due to non-significant hospitalisation outcomes/p-values and to be a hanging comparison.
Trixeo HCP website (GB-29626, DOP June 2021): Bevespi “prescribing information” link appeared as the first mention of Bevespi but did not include the non-proprietary name; Symbicort (as budesonide/formoterol) was referenced on the home/efficacy/safety pages and in a “Breaking Boundaries in COPD” video without providing Symbicort prescribing information or stating where it could be found.
Trixeo “Learn more” page: Eklira and Daxas were mentioned via prescribing information links without non-proprietary names adjacent to the first mention.
Trixeo dosing page: complaint alleged lung deposition claim was based on in vitro data; AstraZeneca said it was based on two human studies and the page footnote said so.

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Symbicort dosing statement: ruled misleading due to omissions (no upper limit; omitted SPC warning to seek medical advice if >16 actuations daily) and not capable of substantiation as presented; high standards not maintained; and breach of Clause 2 (particular censure) due to importance of accurate dosing information and patient safety implications.
Trixeo digital ad: no breach on the narrow allegations (Panel did not accept it was comparative/hanging comparison; did not accept p-value omission made it misleading in that context).
Trixeo website (home/efficacy/safety): breaches for missing non-proprietary name adjacent to first mention in Bevespi PI link; and missing Symbicort prescribing information plus missing statement of where it could be found.
Trixeo “Learn more” page: breach for missing non-proprietary names for Eklira and Daxas in PI links; and breaches for missing Symbicort prescribing information and missing statement of where it could be found for the video that mentioned Symbicort.
Overall: despite multiple breaches, Panel did not rule an overall Clause 2 breach for the whole set of materials (Clause 2 was already applied to the Symbicort dosing issue).

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Clause 2 (Breach – Symbicort dosing webpage; No breach – other parts/overall circumstances)
Clause 5.1 (Breach – Symbicort dosing webpage; Breach – Trixeo website pages where PI requirements not met; No breach – Trixeo digital ad; No breach – Trixeo dosing page)
Clause 6.1 (Breach – Symbicort dosing statement omissions; No breach – Trixeo digital ad; No breach – Trixeo dosing page)
Clause 6.2 (Breach – Symbicort dosing statement not capable of substantiation as presented; No breach – Trixeo digital ad; No breach – Trixeo dosing page)
Clause 12.1 (Breach – missing Symbicort prescribing information on Trixeo pages/video)
Clause 12.3 (Breach – missing non-proprietary names adjacent to first mention for Bevespi/Eklira/Daxas PI links)
Clause 12.4 (Breach – missing Symbicort prescribing information on Trixeo pages/video)
Clause 12.6 (Breach – no statement as to where Symbicort prescribing information could be found on relevant Trixeo pages/video)

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