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FDA approves extension for ACCRUFeR®
Shield Therapeutics plc announced that the US FDA has approved an expanded indication for ACCRUFeR® to include adolescents aged 10 years and older with iron deficiency, following positive results from a Phase 3 pediatric trial. The company plans to seek further approval for a new pediatric formulation, a ferric maltol suspension, for children aged 1 month and above, which could also serve as an alternative for adults unable to swallow capsules. This expansion significantly broadens the market for ACCRUFeR®, which is already the number one branded prescription oral iron in the US market. Disclaimer*
About this update from Shield Therapeutics Plc
[{"type":"text","content":"\n\nShield Therapeutics plc\n(\"Shield\" or the \"Company\" or the \"Group\")\n \nUS FDA approves extension of the indication for ACCRUFeR® to include\nchildren 10 years and older with iron deficiency (ID)\n \nLondon, UK, 22 December 2025: Shield Therapeutics plc (LSE: STX), a commercial-stage pharmaceutical company specialising in iron deficiency, announces that the US Food and Drug Administration (FDA), following a priority review of the clinical supplement, has approved the extension of the indication for ACCRUFeR® (ferric maltol) to include adolescents. ACCRUFeR® is now indicated for the treatment of iron deficiency in adult and pediatric patients 10 years of age and older.\n \nThe indication expansion was supported by positive results from the Phase 3 pediatric clinical trial (FORTIS/ST10-01-305) that confirmed the efficacy, safety, and tolerability of the new oral liquid pediatric formulation in children aged 1 month and above with iron deficiency, presenting as iron deficiency anemia (IDA).\n \nShield plans to file for a further extension of the indication to include children 1 month and above in conjunction with the submission of an NDA for a new pediatric formulation (ferric maltol suspension) which was used in the successful FORTIS Phase 3 study in this population. If approved, this formulation may also offer an alternative approach for adults who can't swallow our current capsule formulation.\n \nAnders Lundstrom, CEO of Shield, commented: \"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.\"\n \nFor further information please contact:\n \n\n\n\n\nShield Therapeutics plc\n\n\nwww.shieldtherapeutics.com\n\n\n\n\nAnders Lundstrom, CEO\nSantosh Shanbhag, CFO\nStephanie Hicks, Investor Relations\n\n\n+44 (0) 191 511 8500\[email protected]\n\n\n\n\n \nNominated Adviser and Joint Broker\n\n\n\n\n\n\n\nPeel Hunt LLP\n\n\n\n\n\n\n\nJames Steel/Christopher Golden\n\n\n+44 (0)20 7418 8900\n\n\n\n\n\n\n\n\n\n\n\n\nJoint Broker\nCavendish Ltd\nGeoff Nash/ Isaac Hooper/Nigel Birks/Harriet Ward &nb...