Amag Says Iron Replacement Therapy Results Positive

RxTrials Institute Drug Pipeline Alert
April 9, 2008 | Vol. 6 No. 15

Amag Says Iron Replacement Therapy Results Positive

Amag Pharmaceuticals has reported positive efficacy and safety results from four Phase III trials of its IV iron replacement therapy ferumoxytol.

Three of the studies evaluated the drug’s safety and efficacy in 875 patients with chronic kidney disease. Patients received either two 510-mg doses of ferumoxytol within approximately one week or 200 mg of oral iron daily for three weeks. Both groups were followed for 35 days.

Aggregate results showed a statistically significant greater mean increase in hemoglobin from base line to day 35 in patients receiving ferumoxytol compared with patients receiving oral iron, the company said. Patients’ hemoglobin increased approximately 1 g/dL during this period for each stage of the disease.

The fourth study was a randomized, double-blind, placebo-controlled crossover safety study enrolling 40 peritoneal dialysis patients, 255 hemodialysis patients and 413 patients not dependent on dialysis. Patients received an injection of either 510 mg ferumoxytol or saline placebo on day zero and a second treatment on day seven.

Amag President and CEO Brian Pereira said the company wants to commercialize ferumoxytol to treat iron deficiency anemia in patients with chronic kidney disease and expects the FDA to rule on its NDA in late October.

http://fdanews.com/newsletter/article?issueId=11475&articleId=105647

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