Norgine voluntary admission: Feraccru non-inferiority claims based on inaccurate statistical reporting (AUTH/3326/3/20)

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Key facts

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Case number	AUTH/3326/3/20
Company	Norgine
Product	Feraccru (oral ferric maltol)
Indication (as stated)	Adults for the treatment of iron deficiency
Issue	Claims based on inaccurate statistical reporting; non-inferiority conclusion drawn from PP alone when protocol required both ITT and PP
Study referenced	AEGIS-H2H (multicentre phase 3b, open-label randomised control trial) vs IV ferric carboxymaltose in iron deficiency anaemia in patients with inflammatory bowel disease
Problem source	Abstract (Howaldt et al 2019) mis-stated primary endpoint criteria (“either ITT or PP”)
Claims at issue	“In the new head-to-head trial, Feraccru was found to be non-inferior to IV ferric carboxymaltose”; “Feraccru may be an appropriate alternative to IV iron for treatment of [iron deficiency anaemia]”
Applicable Code year	2019
Breach clause(s)	Clause 7.2
Complaint type	Voluntary admission (treated as a complaint under Paragraph 5.6 of the Constitution and Procedure)
Complaint received	19 March 2020
Case completed	28 April 2020
Appeal	No appeal
Sanctions	Undertaking received; additional sanctions not stated

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

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Norgine made claims for Feraccru (oral ferric maltol) including: “In the new head-to-head trial, Feraccru was found to be non-inferior to IV ferric carboxymaltose” and “Feraccru may be an appropriate alternative to IV iron for treatment of [iron deficiency anaemia]”.
The claims were based on the AEGIS-H2H study abstract (Howaldt et al 2019), which inaccurately described the primary endpoint as being met in either the ITT or PP population.
The study protocol/statistical analysis plan required non-inferiority to be shown in both ITT (Intention to Treat) and PP (Per Protocol) analyses at week 12 (difference in responders <20% in both).
In the ITT analysis, Feraccru did not demonstrate non-inferiority vs IV ferric carboxymaltose, so the primary endpoint was not met as specified in the protocol.
Norgine stated the inaccurate statistical reporting was from a study “not under Norgine’s control” (in-licensed medicine context).
After identifying the issue, Norgine promptly withdrew training, marketing and market access materials containing the claims (by close of business 9 March) and briefed salesforce and other externally facing staff; it also worked to communicate with third parties with whom the data had been shared.

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Breach ruled (as acknowledged by Norgine).
The Panel found the claims were inaccurate because they relied on a flawed conclusion of non-inferiority based on PP results alone, contrary to the protocol requirement for both ITT and PP.
No appeal.

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