GSK v Actelion: Opsumit promotion and misleading presentation of composite endpoints (AUTH/2709/4/14)

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Key facts

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Case number	AUTH/2709/4/14
Parties	GlaxoSmithKline v Actelion
Product	Opsumit (macitentan)
Therapy area	Pulmonary arterial hypertension (PAH)
Materials	Detail aid OPS 13/0038; Leavepiece OPS 13/0039
Main issue	Presentation of composite endpoints (morbidity–mortality; PAH-related death or hospitalisation) implying mortality benefit without sufficient context
Complaint received	29 April 2014
Case completed	02 July 2014
Applicable Code year	2014
Breach clauses	Clause 7.2 (x3), 7.5 (x2), 7.8, 7.10, 9.1
No breach clauses	Clause 10.2
Sanctions	Undertaking received; Additional sanctions: Not stated

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

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GlaxoSmithKline (GSK) complained about Actelion’s promotion of Opsumit (macitentan) for pulmonary arterial hypertension (PAH) using a detail aid (OPS 13/0038) and a leavepiece (OPS 13/0039).
The materials presented results from Pulido et al (2013), including the composite primary endpoint described as “morbidity-mortality” and a composite secondary endpoint of PAH-related death or hospitalisation.
GSK’s core concern: the promotional claims and graphs did not make clear that the statistically significant effect in the composite endpoints was driven by morbidity (eg worsening PAH) or hospitalisation, not mortality.
Key claims challenged included: “reducing morbidity-mortality”, “Sustained risk reduction from the start of therapy”, “first study to demonstrate morbidity-mortality in stable PDE5i patients”, “Reduced risk of PAH-related death or hospitalisations”, and a leavepiece claim of “38% reduction… in morbidity-mortality at 3 years”.
The Panel noted the specialist setting (specialist PAH centres and referrers) but found the context and lack of supporting detail could still mislead readers into assuming a significant mortality benefit.

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Breach found: Clause 7.2 (x3), Clause 7.5 (x2), Clause 7.8, Clause 7.10, Clause 9.1.
No breach: Clause 10.2.
The Panel concluded the materials were not sufficiently complete for health professionals to form their own opinion about the full therapeutic value of Opsumit in the way the composite endpoints were presented.

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