Shield Therapeutics has announced it has received FDA approval for ACCRUFeR (ferric maltol) for the treatment of iron deficiency in children aged 10 and older.
This makes the medicine the first and only prescription oral iron therapy specifically approved for this pediatric population, having already been FDA-approved and prescribed for adults with iron deficiency since 2019.
Why this matters
Iron deficiency impacts approximately 2.4 million children in the United States, with adolescents being particularly vulnerable.
Up to 40% of females aged 12 to 21 may be affected due to menstruation and the increased iron requirements associated with puberty.
Other common risk factors include insufficient intake of iron-rich foods, high-intensity athletic training, obesity and growth spurts.
It is crucial to identify and treat iron deficiency early in children.
If left unnoticed or untreated, iron deficiency can lead to developmental delays, difficulties with learning and concentration, decreased academic performance, behavioural issues and a weakened immune system.
Many families have faced challenges with traditional iron supplements, as these can lead to stomach upset, nausea, or constipation.
These side effects often make it hard for children to adhere to their treatment.
ACCRUFeR was specifically designed with tolerability in mind. For children aged 10 and older, ACCRUFeR offers a new option to help restore iron levels while minimising the risk of gastrointestinal side effects.