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- The Korean Ministry of Food and Drug Safety has granted regulatory approval for ACCRUFeR (ferric maltol) to treat iron deficiency in adult subjects in South Korea. - The approval follows successful completion of a pharmacokinetic study confirming comparable iron absorption between South Korean patients and populations from key clinical studies. - Shield Therapeutics is eligible to receive payments upon first sale, performance-based sales milestones, and royalties on net sales through its partnership with Korea Pharma. - The approval expands access to ACCRUFeR for patients among the 5.2 million people living with iron deficiency in Korea.
- The FDA has granted Priority Review status to Shield Therapeutics' ACCRUFeR (ferric maltol) for treating iron deficiency anemia in adolescents aged 10 years and above, with approval anticipated in 2026. - The regulatory submission follows positive results from the Phase 3 FORTIS pediatric clinical trial that demonstrated efficacy, safety, and tolerability of the new oral liquid pediatric formulation. - Shield plans to further extend the indication to children as young as 1 month old through a separate NDA submission for a pediatric suspension formulation. - The company's EU partner Norgine has also filed for regulatory approval with the EMA for the adolescent population, targeting 2026 approval.
