FERWON Phase 3 Clinical Trials
The safety and efficacy of two different intravenous irons for treatment of iron deficiency anemia (IDA) were evaluated in two randomized, open-label, actively-controlled Phase 3 clinical trials performed in a total of 3050 patients with IDA of different etiology. Additional analyses were performed from these data.
This section includes links to Pharmacosmos sponsored- publications. Information contained in these publications may include information that is inconsistent with the FDA approved use of product(s). Pharmacosmos does not recommend the use of its products in a manner that is inconsistent with FDA-approved labeling.
*Ferric derisomaltose is marketed as Monofer in some countries outside the US. The term ferric derisomaltose (FDI) has replaced iron isomaltoside (IIM).
September 2019 I Am J Hematol
A prospective, multi-center, randomized comparison of iron isomaltoside* 1000 versus iron sucrose in patients with iron deficiency anemia; the FERWON-IDA trial
Auerbach M, Henry D, Derman RJ, et al.
January 2021 I Nephrol Dial Transplant
Safety and efficacy of iron isomaltoside 1000/ferric derisomaltose versus iron sucrose in patients with chronic kidney disease: the FERWON-NEPHRO randomized, open-label, comparative trial
Bhandari S, Kalra PA, Berkowitz M, et al.
August 2021 I Am J Cardiol
Safety and Efficacy of Intravenous Ferric Derisomaltose Compared to Iron Sucrose for Iron Deficiency Anemia in Patients with Chronic Kidney Disease With and Without Heart Failure
Ambrosy AP, von Haehling S, Kalra PR, et al.
October 2020 I Am J Hematol
A 6 month extension trial evaluating safety and efficacy of ferric derisomaltose in patients with iron deficiency anemia: The FERWON-EXT trial
Achebe MM, Glaspy J, Kalra PA, et al.
January 2021 I Am J Hematol
Safety of ferric derisomaltose and iron sucrose in patients with iron deficiency anemia: The FERWON-IDA/NEPHRO trials
Wolf M, Auerbach M, Kalra PA et al.