EMA Approves Shield Therapeutics' FeRACCRU for Adolescents Following FDA Pediatric Authorization

The European Medicines Agency has approved the extension of Shield Therapeutics' FeRACCRU® (ferric maltol) to include adolescents, following the U.S. Food and Drug Administration's approval of ACCRUFeR® for children age 10 and older in December 2025. FeRACCRU® will now be indicated for the treatment of iron deficiency in adult and pediatric patients 12 years of age and older in the European Union, while ACCRUFeR® has been FDA-approved for children age 10 and older since February 2026.

The EMA confirmed their adoption of a positive opinion for the extension of the indication for FeRACCRU® to include adolescents, and also confirmed that all measures in the agreed Pediatric Investigation Plan for FeRACCRU® have been fulfilled. The 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.

Shield's licensing partner, Norgine B.V. holds the marketing authorisation and is responsible for commercialising FeRACCRU® in the European Union. Shield will receive a milestone payment of €500,000 from Norgine related to this EMA approval for the term of the agreement.

ACCRUFeR® has been FDA-approved and prescribed for adults with iron deficiency since 2019. Iron deficiency affects about 2.4 million children in the United States, with adolescents at a particularly high risk. Up to 40% of females age 12-21 may be affected due to menstruation and increased iron needs during puberty.

ACCRUFeR®/FeRACCRU® (ferric maltol) is a novel, stable, non-salt-based oral therapy for adults and children with iron deficiency with or without anemia. The drug has a novel mechanism of absorption compared to other oral iron therapies and has been shown to be an efficacious and well-tolerated therapy in a range of clinical trials. Together, iron deficiency and iron deficiency anemia affect about 20 million people in the US and represent a $2.3 billion market opportunity.

The Company has launched ACCRUFeR® in the U.S. to include pediatric patients 10 years of age and older with an exclusive, multi-year collaboration agreement with Viatris. Outside of the U.S., the Company has licensed the rights to five specialty pharmaceutical companies. FeRACCRU® is commercialised in the UK and European Union by Norgine B.V., to include pediatric patients 12 years of age and older and also have marketing rights in Australia and New Zealand.