Shield Therapeutics has submitted a new drug application (NDA) with the US Food and Drug Administration (FDA) for its lead product Feraccru to treat iron deficiency.
Feraccru already has an approval for the indication in adults in the European Union. In Switzerland, the drug has been approved for the treatment of iron deficiency anaemia in adults having inflammatory bowel disease.
Shield Therapeutics regulatory affairs and quality VP Jackie Mitchell said: “This NDA submission is a key regulatory milestone in widening Feraccru’s geographical availability for patients suffering from iron deficiency and it builds on the significant broadening of the product’s indication from patients with anaemia and inflammatory bowel disease (IBD) to the treatment of all adults with iron deficiency (ID) with or without anaemia approved in the European Union earlier this year.”
Feraccru is a stable, non-salt and formulation of ferric iron, which is claimed to have differentiated mechanism of action compared to salt-based oral iron therapies.
The UK-based specialty pharmaceutical company said that the US which represents more than a third of the global pharmaceutical market, provides attractive scope for Feraccru.
In the US, Shield Therapeutics will have full ownership of and complete control of the worldwide intellectual property rights.
Shield Therapeutics CEO Carl Sterritt said: “Filing of this NDA is a major step towards the potential regulatory approval of Feraccru in the USA. I am delighted with the rapid progress the team has made with this submission and would also like to thank the clinicians and patients who took part in the studies that have formed part of this NDA.”
Last month, Shield Therapeutics entered into an exclusive license agreement with Norgine for the commercialization of Feraccru in Europe, Australia and New Zealand.
The company said Feraccru is not an iron salt, and iron can be absorbed from the ferric maltol molecule, and as a result, it does not routinely cause the same treatment-limiting intolerance issues.
In clinical trials, Feraccru was demonstrated to be well-tolerated by patients even when they had earlier failed treatment with salt-based oral iron therapies, which should lead to increased patient compliance and better patient outcomes.