Ferinject ferric carboxymaltose: Additional Phase III data

Galenica's Vifor Pharma Ltd. specialty pharma business reported additional data from the 56-week, open-label, international Phase III FIND-CKD trial in 626 non-dialysis dependent CKD patients with iron deficiency anemia evaluating IV Ferinject treatment targeting a serum ferritin level of 400-600 µg/L or 100-200 µg/L vs. oral iron. On the primary endpoint, IV Ferinject targeting 400-600 µg/L serum ferritin increased mean time to initiation of other anemia management, such as erythropoietin stimulating agents (ESAs) or blood transfusions, or time to 2 consecutive hemoglobin values of <10 g/dL during weeks 8-52 vs. oral iron (313 vs. 287 days, p=0.035). IV Ferinject targeting 400-600 µg/L serum ferritin also led to a greater increase in mean hemoglobin levels from baseline to month 12 vs. oral iron (p=0.014). Additionally, IV Ferinject led to a hemoglobin increase of >=1 g/dL in 56.9% of patients in the high serum ferritin group and 34.2% of patients in the low serum ferritin group vs. 32.1% of patients receiving oral iron (p<0.001 for the high serum ferritin group vs. both low serum ferritin group and oral iron group). Patients received IV Ferinject at a starting dose of 200 or 1,000 mg and subsequent dosing as required to maintain guideline-specified serum ferritin levels. Data were presented at the American Society of Nephrology meeting in Atlanta. ...