Lundbeck: complaint about alleged promotion of unlicensed Vyepti via SPS website (AUTH/3475/2/21) – No breach | PMCPA Case

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Key facts

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Case number	AUTH/3475/2/21
Company	Lundbeck
Complainant	Anonymous, contactable health professional
Product	Vyepti (eptinezumab)
Issue alleged	Alleged promotion of a product without a UK marketing authorisation via updates to the UK SPS NHS website referencing US launch/approval status
Third-party channel	Specialist Pharmacy Service (SPS) “New Medicines” monograph
Panel finding	No evidence Lundbeck was involved in updating SPS content; complaint not established on balance of probabilities
Applicable Code year	2019
Clauses considered	2, 3.1, 9.1, 11.1
Outcome	No breach
Complaint received	15 February 2021
Case completed	25 August 2021
Appeal	No appeal

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

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An anonymous, contactable complainant (health professional) raised concerns about alleged promotion of Vyepti (eptinezumab), which did not have a UK marketing authorisation at the time.
The complainant alleged Lundbeck UK had updated the UK Specialist Pharmacy Service (SPS) NHS website entry to reference Vyepti’s US status (FDA-approved/“Launched”), arguing this showed intent to discuss the US market on a UK-based NHS site.
The material at issue was an SPS “New Medicines” monograph for eptinezumab, created June 2017 and last updated November 2020, listing UK/Europe status as “Pre-registration (Filed)” and US status as “Launched”, with key development dates and a brief trial summary.
Lundbeck denied any involvement, stating SPS was an independent, NHS England-commissioned and funded horizon scanning site and that Lundbeck did not provide input (proactively or reactively) into SPS content.
Lundbeck said internal checks (including confirmation from Lundbeck US) found no involvement in updating SPS.

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No breach of the ABPI Code (Applicable Code year: 2019).
The Panel found the complainant had not established, on the balance of probabilities, that Lundbeck had any involvement with the SPS website content.
No appeal.

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