FDA Approves Ferric Maltol for Treatment of Iron Deficiency

The U.S. Food and Drug Administration (FDA) announced its approval of oral ferric maltol for the treatment of iron deficiency in adults.

Ferric maltol is a non-salt formulation of ferric iron that provides an alternative to salt-based oral iron therapies and carries fewer gastrointestinal side effects typically observed with salt-based therapies.

The approval was based on a review of data from the AEGIS-H2H study, in which oral ferric maltol was noninferior to intravenous iron therapy in improving hemoglobin levels, without requiring hospital-based administration, in patients with iron-deficiency anemia.

The proportion of patients who discontinued treatment during previous studies due to adverse events (AEs) was 4.6%, and the most common AE leading to discontinuation of ferric maltol in these studies was abdominal pain (1.7% of patients).

Ferric maltol is already approved in the E.U. for the treatment of iron deficiency in adults. According to the FDA’s prescribing information, ferric maltol should be administered as 30 mg twice daily, taken 1 hour before or 2 hours after a meal. The duration of treatment depends on the severity of iron deficiency, but generally at least 12 weeks of treatment is required.

Source: Shield Therapeutics press release, July 26, 2019.