Replies to post #73 on AMAG Pharmaceuticals (AMAG)

[surf1944]

6:02AM AMAG Pharma announces positive preliminary results from an extension study evaluating the safety and efficacy of repeat dosing with ferumoxytol in patients with persistent or recurring iron deficiency anemia, regardless of the underlying cause; achieved a statistically significant mean increase in hemoglobin from baseline to week five (AMAG) 20.15 : Co announced positive preliminary data from the IDA-303 study. IDA-303 is a single arm, open-label extension study that evaluated the safety and efficacy of repeat dosing with ferumoxytol in patients with persistent or recurring iron deficiency anemia regardless of the underlying cause and a history of unsatisfactory oral iron therapy or in whom oral iron could not be used. Patients were eligible to enroll in the IDA-303 extension study after they completed IDA-301, which was a double-blind, placebo-controlled trial that randomized patients to receive either a one gram intravenous course of ferumoxytol or placebo, the results of which were previously reported by the company and presented at the American Society of Hematology annual meeting in December 2012.

The primary efficacy endpoint of the extension study was the mean change in hemoglobin from baseline to week five following the first course of ferumoxytol. The 151 patients who received their first course of therapy in IDA-303 achieved a statistically significant mean increase in hemoglobin from baseline to week five of 2.6 g/dL. This change was consistent with the 2.7 g/dL increase in hemoglobin reported for ferumoxytol-treated patients in both the IDA-301 and IDA-302 studies. The first secondary endpoint was the mean change in hemoglobin from baseline to week five for each subsequent course of ferumoxytol after treatment course one. The group of patients receiving a second (n=244) and third (n=69) course of treatment with ferumoxytol in IDA-303 included patients who had received ferumoxytol in IDA-301 and patients who had received their first course of ferumoxytol in IDA-303.

No new safety signals were observed with repeat dosing of ferumoxytol and the types of reported adverse events (AEs) were consistent with those seen in both the previously reported IDA and CKD phase III studies, and those contained in the approved U.S. package insert for Feraheme; no hypersensitivity reactions or hypotension were reported in the IDA-303 study.