Prelim. Results from Phase III Trial on AMAG Pharma's (AMAG) Feraheme Met Primary Endpoints
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AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today reported preliminary results from the first of two phase III studies that comprise its global registrational program for Feraheme® (ferumoxytol) in patients with iron-deficiency anemia (IDA) regardless of the underlying cause. The study being reported today compared treatment with Feraheme to treatment with intravenous (IV) iron sucrose, and enrolled 605 patients at 74 sites in Europe, Asia Pacific and Australia. The patients enrolled in the study had a history of unsatisfactory oral iron therapy, and had IDA associated with various conditions including abnormal uterine bleeding, cancer, gastrointestinal disorders or other causes.
The study was an open-label, active-controlled trial that randomized patients 2:1 to receive a one gram IV course of either Feraheme (n=406) or iron sucrose (n=199), and it was powered to demonstrate non-inferiority on efficacy. The demographics and all baseline parameters were well balanced between the two treatment groups. The primary efficacy endpoint of the study was the mean change in hemoglobin from baseline to week five or the proportion of subjects who achieved a ≥ 2.0 g/dL increase in hemoglobin at any time from baseline to week five, depending on the regulatory authority.
In this study, Feraheme achieved the predefined criteria for non-inferiority on both primary efficacy endpoints. Patients treated with Feraheme achieved a mean increase in hemoglobin at week five of 2.7 g/dL, compared to a mean increase of 2.4 g/dL in patients treated with IV iron sucrose. A ≥ 2.0 g/dL increase in hemoglobin at any time from baseline to week five was achieved in 84% of patients treated with Feraheme, compared with 81% of patients treated with IV iron sucrose.
No new safety signals were observed with Feraheme and the types of reported adverse events were consistent with those seen in previous studies and those contained in the U.S. package insert for Feraheme. Overall adverse events (AEs) were comparable between the treatment arms, with AEs reported in 41.4% of Feraheme-treated patients, compared to 44.2% of patients treated with IV iron sucrose.
Patients in both treatment groups experienced protocol-defined adverse events of special interest, which included moderate to severe hypotension or hypersensitivity reactions, ranging from fever alone to an anaphylactoid reaction. Cardiovascular AEs were comparable between the two treatment groups. Serious adverse events (SAEs) were reported in 4.2% of Feraheme-treated patients, compared to 2.5% of patients treated with IV iron sucrose; the SAEs reported in two Feraheme treated patients (0.5%) were reported as related by the investigators.
The study was an open-label, active-controlled trial that randomized patients 2:1 to receive a one gram IV course of either Feraheme (n=406) or iron sucrose (n=199), and it was powered to demonstrate non-inferiority on efficacy. The demographics and all baseline parameters were well balanced between the two treatment groups. The primary efficacy endpoint of the study was the mean change in hemoglobin from baseline to week five or the proportion of subjects who achieved a ≥ 2.0 g/dL increase in hemoglobin at any time from baseline to week five, depending on the regulatory authority.
In this study, Feraheme achieved the predefined criteria for non-inferiority on both primary efficacy endpoints. Patients treated with Feraheme achieved a mean increase in hemoglobin at week five of 2.7 g/dL, compared to a mean increase of 2.4 g/dL in patients treated with IV iron sucrose. A ≥ 2.0 g/dL increase in hemoglobin at any time from baseline to week five was achieved in 84% of patients treated with Feraheme, compared with 81% of patients treated with IV iron sucrose.
No new safety signals were observed with Feraheme and the types of reported adverse events were consistent with those seen in previous studies and those contained in the U.S. package insert for Feraheme. Overall adverse events (AEs) were comparable between the treatment arms, with AEs reported in 41.4% of Feraheme-treated patients, compared to 44.2% of patients treated with IV iron sucrose.
Patients in both treatment groups experienced protocol-defined adverse events of special interest, which included moderate to severe hypotension or hypersensitivity reactions, ranging from fever alone to an anaphylactoid reaction. Cardiovascular AEs were comparable between the two treatment groups. Serious adverse events (SAEs) were reported in 4.2% of Feraheme-treated patients, compared to 2.5% of patients treated with IV iron sucrose; the SAEs reported in two Feraheme treated patients (0.5%) were reported as related by the investigators.
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