FDA OKs Oral Ferric Maltol (Accrufer ) for Iron Deficiency in Adults

Megan Brooks

August 07, 2019

The US Food and Drug Administration (FDA) has approved oral ferric maltol (Accrufer, Shield Therapeutics) for the treatment of iron deficiency in adults.

The product is already approved in the European Union and Switzerland for the treatment of iron deficiency in adults, where it is sold as Feraccru.

"The broad label that the FDA has granted provides a very strong signal as to the tolerability and efficacy profile of Feraccru/Accrufer and provides a novel and convenient treatment alternative to the millions of US patients who routinely suffer with iron deficiency," Jackie Mitchell, vice president of regulatory affairs for Shield Therapeutics, said in a statement announcing the US approval.

Ferric maltol, a nonsalt formulation of ferric iron, provides an alternative to salt-based oral iron therapies, with fewer of the gastrointestinal side effects typically observed with salt-based therapies, the company said.

In the AEGIS-H2H study announced in March 2019, oral ferric maltol was noninferior to intravenous iron therapy in treating iron deficiency anemia

Treatment with ferric maltol "might remove the need for patients to progress to intravenous iron therapy, leading to a change in the current paradigm for the treatment of iron deficiency [anemia]," the company said.

According to the prescribing information, the recommended dosage of ferric maltol is 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. Treatment should be continued as long as necessary until ferritin levels are within the normal range.  

The proportion of patients who discontinued treatment during previous studies due to adverse reactions was 4.6%. The most common adverse reaction leading to discontinuation of Accrufer in these studies was abdominal pain (1.7% of patients), according to the FDA.

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