Shield Therapeutics PLC (LON:STX) has initiated an independent analysis of the nuanced datasets from last year’s AEGIS-H2H clinical trial of its lead product, an iron deficiency drug known as Feraccru here in the UK and Accrufer in the States.
It will assess the methodology used around determining the treatment’s “non-inferiority” against a leading intravenous medication in treating iron deficiency anaemia in adults with inflammatory bowel disease.
Shield stressed that this clarification process will have no impact on either the existing marketing authorisations or prescribing information used in the regulatory submissions that led to the approval of its product in Europe, the US, and Switzerland.
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