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Shield Therapeutics PLC: FDA approves broad label for Feraccru

Shield Therapeutics (LON:STX) reports it has achieved the best possible outcome for Feraccru. The US Food & Drug Administration (FDA) has approved the treatment for a broad label to treat iron deficiency (ID) in adults, addressing a population many times wider than the iron deficiency anaemia (IDA) indications included in the submission data.

Feraccru, an oral treatment for iron deficiency with or without anaemia that will be marketed as Accrufer in the US, is now positioned to directly challenge the market-leading intravenous iron therapy. This is backed by clinical non-inferiority, as well as being a potentially safer and more convenient alternative. STX is well supported to negotiate attractive deal terms with prospective US commercial partners for Accrufer in a total US prescription iron replacement market worth more than US$1bn.

Executive summary

Feraccru, which will be marketed as Accrufer in the US, has obtained the broadest possible label for treating adults with iron deficiency with or without anaemia. There are around three times as many patients with ID than with IDA (source: STX). Adding these, the total addressable population could reach up to 40 million in the US. The announced label also took off the table the prospective limitation to just chronic kidney disease (CKD) and inflammatory bowel disease (IBD) patients as per the studies included in the FDA approval submission. In all Accrufer is poised to approach a US iron replacement therapy prescription market worth more than US$1bn.

The key commercial and clinical considerations supporting Accrufer are its greater convenience compared to intravenous (IV) iron therapy, for those patients unable to tolerate first-line salt-based oral iron treatments. Data from the AEGIS head-to-head (H2H) multi-national Phase IIIb randomised, active-controlled trial, showed non-inferiority to Vifor Pharma’s market-leading IV iron Ferinject (marketed in the US as Injectafer). IV iron is invasive and inconvenient since it needs to be administered in a hospital because it always carries the risk of a severe and potentially fatal allergic reaction.

Furthermore, in the US, Injectafer has a more specific label than Accrufer – the former is indicated first for adults with IDA, for patients who have non-dialysis dependent CKD, and for patients who are intolerant to, or who have an unsatisfactory response to oral irons. Accrufer’s broader label, therefore, favours its commercial prospects.

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