Almirall website claims for Ilumetri: dosing and efficacy headlines ruled misleading (AUTH/3263/11/19)

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Key facts

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Case	AUTH/3263/11/19
Parties	Anonymous complainant v Almirall
Product	Ilumetri (tildrakizumab)
Channel	Company website (Almirallmed.co.uk)
Main issues	Alleged public access to POM promotion; misleading dosing/efficacy/QoL claims
Key claims assessed	“Ilumetri is the only IL-23 inhibitor with just four doses per year and two dosing options”; “Ilumetri demonstrated superior efficacy to placebo at Week 12 and maintains control for >2.5 years in responders (PASI≥75)”; “Ilumetri significantly improves quality of life”
Breach clauses	7.2, 7.4, 9.1, 28.1
No breach clauses	2, 12.1, 14.1, 14.3, 26.1, 28.1 (public-access allegation)
Sanction	Undertaking received
Complaint received	17 October 2019
Case completed	5 August 2020
Appeal	No appeal
Applicable Code year	2019

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

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An anonymous, non-contactable complainant challenged Almirall’s promotional website (Almirallmed.co.uk) for Ilumetri (tildrakizumab), alleging misleading dosing/efficacy claims and that POM promotion was accessible to the public.
The site used a welcome/landing page stating it was intended for health care professionals and asked visitors to choose “I’m a HCP” or “I’m not a HCP”.
The complainant queried why there was also an “Access for Professionals” sign-up area if the site was intended for HCPs.
The Panel considered the public-access allegation narrowly and focused on the headline Ilumetri dosing/efficacy/quality-of-life claims Almirall had addressed.
The Panel assessed whether the headline claims were complete, accurate, and capable of standing alone without relying on implied qualifications.

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No breach was found for alleged advertising of a prescription-only medicine to the public via the website (no breach of Clauses 26.1 and 28.1 on that allegation).
No breach was found for certification and “disguised promotion” allegations (no breach of Clauses 14.1, 14.3, 12.1).
Breach findings were made for misleading/unsupported headline claims about dosing, efficacy and quality of life (breach of Clauses 7.2 and 7.4).
Because of the misleading claims, the Panel ruled the material failed to comply with relevant digital requirements and high standards (breach of Clauses 28.1 and 9.1).
No breach of Clause 2 was ruled.

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