Feraheme Meets Phase III Goals in Iron-Deficient Patients Without Renal Failure

July 20, 2012

(Reuters) Jul 18 - Amag Pharmaceuticals Inc said its anemia drug Feraheme met the main goal of improving hemoglobin levels in patients with iron-deficiency anemia in a phase III trial.

Feraheme (ferumoxytol), which is already approved for intravenous treatment of iron-deficiency anemia in adult chronic kidney disease patients, is now being evaluated as a treatment for iron-deficiency anemia regardless of the underlying cause.

The study, IDA-301, was testing the efficacy of Feraheme on targets set by U.S. and EU health regulators and the trial met both the goals.

The company said in a statement that the U.S. regulators' target - an increase in hemoglobin of at least 2.0 g/dL at any time from baseline to week five -- was achieved in 81.1% of patients treated with Feraheme, compared with only 5.5% of patients who received placebo.

As for the European target, patients treated with Feraheme achieved a statistically significant mean increase in hemoglobin at week five of 2.7 g/dL, compared to a mean increase of only 0.1 g/dL in patients who received placebo.

A significant improvement in fatigue, as assessed by patient reports, was demonstrated at week five in Feraheme-treated patients.

IDA-301 compared Feraheme treatment to placebo in 808 patients at 136 sites in the US, Canada, India, Latvia, Hungary, and Poland, all of whom had failed treated with oral iron therapy. Patients were randomized 3:1 to receive a one gram IV course of Feraheme or placebo

Patients enrolled in this study were eligible to enter an ongoing extension study, IDA-303, to evaluate repeat dosing with Feraheme; the extension study is fully enrolled with 634 patients, the company said.

No new safety signals were observed with Feraheme, according to the company. Overall, AEs were reported in 49.2% of Feraheme-treated patients and 43.0% of patients who received placebo.

Serious adverse events (SAEs) were reported at a comparable frequency in both Feraheme-treated patients (2.6%) and patients who received placebo (3.0%); four of the SAEs in Feraheme-treated patients (0.7%) were reported as related to study drug by investigators.

Amag says the results of IDA-301 are consistent with findings in its IDA-302 study.

"With both phase III studies in our global registrational program for Feraheme now complete, we will seek approval for Feraheme for the treatment of a broader population of patients with iron deficiency anemia," Lee Allen, Amag's chief medical officer, said in a statement.

The company plans to submit a supplemental new drug application for Feraheme by the end of this year.


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