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(Alliance News) - Shield Therapeutics PLC on Tuesday said it has started an independent review into the analysis of data in its clinical trial for Feraccru/Accrufer.
Feraccru/Accrufer is a treatment for iron deficiency in adults with or without anemia.
Earlier in March. the pharmaceutical company had said the clinical trial delivered positive results which demonstrated that its Feraccru/Accrufer treatment was not inferior to a market-leading intravenous iron therapy when treating iron deficiency anaemia in adults with inflammatory bowel disease.
However, Shield on Tuesday said its statement in March was in relation to the 'per protocol' analysis of the study results, and not the 'intention to treat' analysis.
The per protocol analysis refers to those patients who fully complied with the study design and remained on the study for the full 12-week period, while the ITT analysis refers to all patients who were randomised into the study, whether or not they completed the entire 12-week period and fully complied with the study design.
The PP analysis showed non-inferiority. However, the ITT analysis while clearly demonstrating the effectiveness of Feraccru/Accrufer, did not achieve non-inferiority compared to the IV iron therapy.
As a result, Shield said it has started an independent review of both data sets. However, the company stated that the recent developments will not have a negative effect on the approvals already granted for Feraccru/Accrufer.
"This clarification has no impact on existing marketing authorisations, nor on any approved prescribing information and the data was not used in the regulatory submissions that led to the approval of Feraccru/Accrufer in either Europe, the USA or Switzerland," it said.
Feraccru/Accrufer is approved for the treatment of iron deficiency in adults with or without anaemia in the US, the EU and Switzerland. Commercial partners including Norgine BV and Beijing Aosaikang Pharmaceutical Co Ltd have licensed the rights to Feraccru/Accrufer in the European Union, Australia, New Zealand and China.
By Ife Taiwo; ifetaiwo@alliancenews.com
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