Comparison Study for Iron Deficiency Anemia Treatment Yields Positive Results

Ferric maltol (Feraccru) met its primary endpoint when compared with ferric carboxymaltose (Ferinject, Daiichi-Sankyo), and delivered a hemoglobin (Hb) response rate at 12 weeks, which was within 9% of the effect seen with a market leading IV iron treatment (IVI FCM), according to a news release from Shield Therapeutics and Norvine BV. The novel oral iron replacement therapy was efficiently absorbed and well tolerated during the treatment period.

In the study, the oral medication ferric maltol demonstrated increases in Hb levels similar to that of IV ferric carboxymaltose. Current oral iron treatments can be poorly tolerated and ineffective, which can contribute to patients needing IV iron in hospital. However, ferric maltol’s potency means that patients with iron deficiency anemia (IDA) may have a long-term and well tolerated alternative treatment option so as to bypass time consuming and expensive hospital administration like IV.

Shield’s preliminary results for 2018 will be presented in early April 2019. This presentation will include such as secondary endpoints and safety parameters. The full data will be submitted for peer-review and subsequent presentation.

A New Drug Application in the USA is being reviewed by the FDA with a PDUFA date of 27 July 2019.

Reference

Important new trial with oral FERACCRU shows comparable efficacy to IV iron (ferric carboxymaltose), offering a real alternative to Hospital Administration for Many patients [news release]. Amsterdam, Netherlands. Published March 4, 2019. https://markets.businessinsider.com/news/stocks/important-new-trial-with-oral-feraccru-shows-comparable-efficacy-to-iv-iron-ferric-carboxymaltose-offering-a-real-alternative-to-hospital-administration-for-many-patients-4-1028000557. Accessed March 4, 2019.