Takeda breached Clause 7.11 by calling Takhzyro “new” more than 12 months after promotion began

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Key facts

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Case	AUTH/3354/5/20
Company	Takeda
Complainant	Concerned health professional
Medicine	Takhzyro (lanadelumab)
Indication (as stated)	Routine prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and older
Material/channel	Hosted webpage on the BMJ website accessed via banner advertisement (ref C-APROM/UK//3323)
Claim at issue	“Introducing Takhzyro: a new preventative treatment for use in type I/II HAE”
Marketing authorisation date	22 November 2018
Panel view: promotion began	1 April 2019 (based on certified promotional presentation)
Complaint received	25 May 2020
Case completed	08 February 2021
Applicable Code year	2019
Breach clauses	Clause 7.11
Appeal	No appeal
Sanctions	Undertaking received; additional sanctions not stated

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

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A health professional complained about a BMJ-hosted promotional webpage/banner journey for Takhzyro (lanadelumab) stating: “Introducing Takhzyro: a new preventative treatment for use in type I/II HAE”.
The complainant argued the marketing authorisation was granted over 12 months earlier.
Takeda said “new” was permissible because it considered Takhzyro “generally available” from 18 September 2019 (linked to NICE appraisal outcome communications) and the hosted webpage was certified 25 October 2019.
Takeda also noted first commercial stock supply into the UK was 26 June 2019 and first UK commercial order was received in December 2019.
The Panel reviewed earlier Takeda-responsible presentations (1 April 2019 and 2–3 May 2019) and found them clearly promotional and certified as such.
The Panel concluded Takhzyro had been promoted from 1 April 2019; therefore “new” could only be used for 12 months from that date.
The ad appeared to have been viewed around the end of May 2020 (complaint submitted 25 May 2020), i.e., beyond the 12-month window.

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