Data from Pharmawand - Curated by EPG Health - Date added 02 October 2018

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.

Comments

You will need to login, to leave a comment.

epgonline.org is not monitored for collection of adverse event reports. Any adverse events should be reported to your national reporting agency and/or the manufacturer.

Learning Zones

An epgonline.org Learning Zone (LZ) is an area of the site dedicated to providing detailed self-directed medical education about a disease, condition or procedure.

Chronic Lymphocytic Leukaemia (CLL)

Chronic Lymphocytic Leukaemia (CLL)

Refine your knowledge of chronic lymphocytic leukaemia (CLL) with information on pathophysiology, diagnosis, treatment options and more

+ 1 more

Fluid Management

Fluid Management

Are you up-to-date with the latest evidence of effective procedures for fluid management?

+ 2 more

Migraine Knowledge Centre

Migraine Knowledge Centre

The Migraine Knowledge Centre features latest research on the prevalence and impact of migraine, the proposed neurological basis of the condition (and how this is being translated into new and exciting drug therapies), as well as current patient care strategies collated from headache organisations worldwide.

Load more

Related Content