Feraccru filed with FDA for iron deficiency.- Shield Therapeutics.

Shield Therapeutics has announced that it has received confirmation from the US FDA of its successful submission of an NDA for Feraccru (ferric maltol), Shield�s lead product, which is already approved in the European Union for the treatment of iron deficiency in adults and in Switzerland for the treatment of iron deficiency anaemia in adults with inflammatory bowel disease.

Comment: Feraccru failed to meet its endpoint in a phase III trial reported in February 2018. Currently, the only treatment option for IDA patients who cannot tolerate salt-based oral iron therapies, is IViron therapy. IV iron therapies quickly increase iron stores via direct administration of very large doses of iron, causing an increase in Hb levels that is physiologically controlled and occurs over a period of weeks, as is the case with Feraccru. IV iron therapies, however, are invasive, costly, inconvenient and complex to administer, and also come with potentially life-threatening, spontaneous hypersensitivity reactions. Feraccru has been approved by the European Commission for the treatment of iron deficiency in adults, with or without anaemia.