Shield Therapeutics Receives FDA Approval for ACCRUFeR® in Pediatric Patients
Shield Therapeutics plc has announced that the U.S. Food and Drug Administration (FDA) has approved ACCRUFeR® (ferric maltol) for the treatment of iron deficiency in children aged 10 years and older.
The medicine has been approved for adults with iron deficiency since 2019. It is the first and only prescription oral iron therapy specifically approved for this age group in the United States.
Iron deficiency affects an estimated 2.4 million children in the U.S., with adolescents at increased risk.
Up to 40 per cent of females aged 12 to 21 may be affected due to menstruation and higher iron requirements during puberty.
Other risk factors include low intake of iron-rich foods, intense athletic training, obesity and rapid growth.
Early diagnosis and treatment are important. Untreated iron deficiency may lead to developmental delays, learning difficulties, poor concentration, behavioural problems and reduced immunity.
Common symptoms include tiredness, pale skin, irritability and reduced performance at school or in activities. Parents with concerns are advised to consult a healthcare professional, who may recommend blood tests.
Traditional iron supplements can cause stomach upset, nausea or constipation, which may affect adherence. ACCRUFeR® has been developed to improve tolerability while effectively restoring iron levels.
