FERAHEME demonstrated non-inferior efficacy in patients with and without chronic kidney disease (CKD)1

IDA TRIAL 2
FERAHEME was non-inferior to Venofer® (iron sucrose) in raising Hgb levels ≥2.0 g/dL at any time from baseline to Week 52*

Proportion of patients with Hgb increase of ≥2.0 g/dL at any time from baseline to Week 51,2

  • 84.0%

    341 patients
    FERAHEME Baseline Hgb: 8.9
    (n=406)
  • 81.4%

    162 patients
    Venofer® Baseline Hgb: 8.8
    (n=199)

2.6%DIFFERENCE

(95% Cl, -3.9 to 9.1)

Non-inferiority
margin: -15%

FERAHEME met the predefined criteria for non-inferiority to Venofer®.2

*Venofer® is an iron replacement product indicated for the treatment of iron deficiency anemia in patients with CKD.4

FERAHEME was non-inferior to Venofer® (iron sucrose) in mean Hgb rise from baseline2,5

Mean change in Hgb from baseline to Week 52,5†

  • Mean change in Hgb from baseline to Week 5 was 2.9±1.6 g/dL for FERAHEME-treated patients and 2.7±1.3 g/dL for Venofer®-treated patients (treatment difference=0.3 g/dL [95% CI, 0.06 to 0.52], non-inferiority margin: -0.5 g/dL)1,5

n values represent the intent-to-treat population.

CI=confidence interval; Hgb=hemoglobin; IDA=iron deficiency anemia.

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CKD TRIAL
In a non-inferiority study, FERAHEME demonstrated comparable efficacy with Venofer® (iron sucrose) in iron deficiency anemia patients with chronic kidney disease (CKD)3

The CKD Trial included both dialysis-dependent and non-dialysis-dependent patients1

Mean change in Hgb from baseline to Week 53

Error bars represent 95% CI.

  • Comparable increases in Hgb were achieved in both treatment groups from baseline to Week 53

Primary efficacy endpoint: mean change in Hgb from baseline to Week 51,3

  • 0.71g/dL

    ±1.03
    FERAHEME (n=80)
  • 0.61g/dL

    ±0.97
    Venofer® (n=82)

0.1g/dLDIFFERENCE

(95% Cl, -0.21 to 0.41)

Non-inferiority
margin: -0.5 g/dL

96% of FERAHEME-treated patients
completed both doses of the study medication in the CKD Trial3

Select Important Safety Information: The most common adverse reactions (≥2%) are diarrhea, headache, nausea, dizziness, hypotension, constipation, and peripheral edema.

CI=confidence interval; Hgb=hemoglobin; IDA=iron deficiency anemia.

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