Shield Therapeutics’ iron deficiency drug Feraccru has been accepted for review by the US Food and Drug Administration (FDA).
Feraccru (ferric maltol) is already approved in the EU for the treatment of iron deficiency in adults and in Switzerland for the treatment of iron deficiency anaemia in adults with inflammatory bowel disease.
The drug is a novel, stable, non-salt, oral formulation of ferric iron, which has a differentiated mechanism of action compared to salt-based oral iron therapies.
In clinical trials it was shown to be well-tolerated by patients even when they had previously failed treatment with salt-based oral iron therapies, which should lead to increased patient compliance and better patient outcomes.
Commenting on the announcement, Dr Jackie Mitchell, VP of Regulatory Affairs and Quality at Shield, said: “We are delighted to have achieved this key regulatory milestone in widening Feraccru’s geographical availability for patients suffering from iron deficiency.
“We look forward to interacting positively with the FDA over the coming months and, if approved, Feraccru will provide a novel and much needed treatment option for patients with iron deficiency.”
In September Norgine signed a deal with Shield allowing it to commercialise Feraccru in Europe, Australia and New Zealand.