Novartis breached ABPI Code over ‘Think Symptom-free’ claim for Xolair on HCP website (AUTH/3638/4/22)

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Key facts

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Case number	AUTH/3638/4/22
Company	Novartis
Complainant	Healthcare professional (became non-contactable)
Medicine	Xolair (omalizumab)
Channel	Novartis-owned UK HCP website (health.novartis.co.uk) promotional webpages
Therapy areas/pages	Dermatology (CSU) landing page; Respiratory (SAA) landing page
Main issue	“THINK Symptom-free” in CSU implied all patients would be symptom free/complete response
Applicable Code year	2021
Complaint received	24 April 2022
Case completed	20 April 2023
Appeal	No appeal
Breach clauses	Clause 6.1; Clause 6.2; Clause 5.1
No breach clauses (as ruled in this case)	Clause 2; Clause 6.1 (for “UNLOCK LIFE”); Clause 6.2 (for “UNLOCK LIFE”); Clause 5.1 (for “UNLOCK LIFE*” and other elements); Clause 11.2
Sanction	Undertaking received

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

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A healthcare professional complained about promotional messaging for Xolair (omalizumab) on Novartis’ UK HCP website (health.novartis.co.uk), covering pages for Chronic Spontaneous Urticaria (CSU) and Severe Allergic Asthma (SAA).
On the CSU dermatology landing page, a feature image included: “In chronic spontaneous urticaria, THINK Symptom-free, THINK IgE, THINK Xolair (omalizumab).” plus “Block IgE, UNLOCK LIFE*”.
The complainant alleged “THINK Symptom-free” implied patients would have no symptoms (i.e., 100% symptom free), which was not supported by evidence.
The complainant also challenged “UNLOCK LIFE*” (CSU and SAA) as an inappropriate quality-of-life claim and argued footnotes should not be used to qualify claims.
On the SAA respiratory landing page, the complainant alleged “In severe asthma…” implied use beyond the licensed indication, and that an image of a man jumping implied unrealistic activity improvements.
Novartis accepted breaches for the CSU “Think symptom-free” wording (Clauses 6.1 and 6.2) and said it would withdraw CSU materials using that statement and not use it in future.

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Breach for CSU page claim “THINK Symptom-free” because it misleadingly implied all patients would be symptom free / achieve complete response; most patients did not (SPC complete response cited as 34–44%).
No breach for “UNLOCK LIFE*” (CSU and SAA): Panel considered the claim capable of standing alone; footnotes were additional useful information rather than required qualification; complainant did not establish the claim was misleading or unsubstantiated.
No breach for “severe asthma” context on SAA page: Panel did not consider the page implied Xolair was for any severe asthma patient outside the licence (noting “THINK Allergy”, antibody imagery, and the licensed indication shown below).
No breach for the jumping-man image on SAA page: Panel did not consider it failed to maintain high standards on the evidence provided.
No breach of Clause 2 overall: Panel did not consider the circumstances warranted “particular censure”, and the complainant did not establish lack of experience/understanding/integrity.

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Breach of Clause 6.1 Making a misleading claim
Breach of Clause 6.2 Making an unsubstantiated claim
Breach of Clause 5.1 Failing to maintain high standards
No Breach of Clause 2 Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
No Breach of Clause 6.1 Requirement that information must be accurate, up-to-date and not misleading
No Breach of Clause 6.2 Requirement that claims must be capable of substantiation
No Breach of Clause 5.1 Requirement to maintain high standards
No Breach of Clause 11.2 Requirement that a medicine must be promoted in accordance with the terms of its marketing authorisation and must not be inconsistent with the particulars listed in its summary of product characteristics

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