Shield Therapeutics has revealed that the US Food and Drug Administration will make a decision on its application to market Feraccru in the US by July 27 next year.
Feraccru (ferric maltol), the firm’s lead product, for low iron stores in the body, 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.
Feraccru is already approved in the European Union for the treatment of iron deficiency in adults, in Switzerland for the treatment of iron deficiency anaemia in adults with inflammatory bowel disease, and was also launched across the UK earlier this month.
Currently in the US, the only treatment option for IDA patients who cannot tolerate salt-based oral iron therapies is IV iron therapy, which is invasive, costly, inconvenient and complex to administer, and also causes potentially life-threatening reactions, the firm notes.
“We are delighted to have confirmation of the PDUFA target review action date, a key regulatory milestone in widening Feraccru’s geographical availability for patients suffering from iron deficiency,” Dr Jackie Mitchell, VP quality and regulatory affairs at Shield, said of the development.
“We are looking forward to interacting positively with the FDA over the coming months and, in parallel, we will be seeking an attractive commercial partner for Feraccru in the USA who can help us realise the full value of the opportunity that would be created by Feraccru’s approval.
“If approved, Feraccru will provide a novel and much needed treatment option for patients with iron deficiency.”