Shield Therapeutics plc (LSE: STX), a pharmaceutical company that specialisies in iron deficiency, announced on Monday that the US Food and Drug Administration has approved an extension of the indication for ACCRUFeR (ferric maltol) to include paediatric patients aged 10 years and older, following a priority review. ACCRUFeR is now indicated for the treatment of iron deficiency in both adult and paediatric patients from age 10.

Approval was supported by positive Phase 3 data from the FORTIS/ST10-01-305 paediatric trial, which confirmed the efficacy, safety and tolerability of a new oral liquid formulation in children aged one month and above with iron deficiency presenting as iron deficiency anaemia.

Shield Therapeutics plc plans to seek a further label extension to include children from one month of age, alongside submission of a New Drug Application for the paediatric ferric maltol suspension used in the Phase 3 study. The company said the formulation could also provide an alternative for adult patients unable to swallow capsules.

Iron deficiency and iron deficiency anaemia affect around 20 million people in the US, representing an estimated USD2.3bn market opportunity. ACCRUFeR is currently the only FDA-approved oral iron therapy for iron deficiency and iron deficiency anaemia and is the leading branded prescription oral iron in the US market.