FDA approves label extension for Shield's Accrufer
By Josh White
Date: Monday 22 Dec 2025
(Sharecast News) - Shield Therapeutics said on Monday that the US Food and Drug Administration (FDA) has approved an extension of the indication for its iron deficiency treatment Accrufer to include paediatric patients aged 10 years and older, following a priority review.
The AIM-traded pharmaceutical company said Accrufer, which contains ferric maltol, is now indicated for the treatment of iron deficiency in both adult and paediatric patients aged 10 and above.
It said the expanded indication was supported by positive results from the phase three 'FORTIS/ST10-01-305' paediatric trial, which confirmed the efficacy, safety and tolerability of a new oral liquid paediatric formulation in children aged one month and above with iron deficiency presenting as iron deficiency anaemia.
Shield said it planned to seek a further extension of the indication to include children aged one month and above alongside the submission of a new drug application for the paediatric formulation, a ferric maltol suspension, which was used in the successful phase three study.
If approved, the company said the liquid formulation could also provide an alternative option for adult patients who were unable to swallow the current capsule formulation.
"We are delighted with the FDA approval of Accrufer, making it available to the adolescent population, who now can benefit from a much needed safe and effective oral iron treatment," said Anders Lundstrom, chief executive of Shield Therapeutics.
At 1153 GMT, shares in Shield Therapeutics were up 2.22% at 11.5p.
Reporting by Josh White for Sharecast.com.
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