AMAG Pharmaceuticals 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. No new safety signals were observed with repeat dosing of ferumoxytol and the types of reported adverse events 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. Approximately 48% of patients who received ferumoxytol treatment course one in this study experienced an adverse event, consistent with the AE rate reported in the IDA-301 study; in each of treatment courses two and three, approximately 38% of patients experienced an AE. Approximately 5% of ferumoxytol-treated patients in this study experienced a serious adverse event in each of the three treatment courses, none of which were deemed related to treatment by study investigators.
- Pharmaceuticals & Drug Trials