AMAG Pharmaceuticals announced that it has submitted a supplemental new drug application (sNDA) to the FDA for Feraheme (ferumoxytol) Injection; the sNDA seeks to expand the drug’s indication to all adult patients with iron deficiency anemia (IDA) who have failed or could not tolerate oral iron treatment. Ferumoxytol consists of a superparamagnetic iron oxide that is coated with a carbohydrate shell.
The submission is based on data from a global Phase 3 program that evaluated the use of ferumoxytol in a broad range of adult IDA patients, all of whom had failed or could not tolerate oral iron treatment. More than 1,400 patients were enrolled in the two Phase 3 clinical trials, IDA-301 (placebo comparator) and IDA-302 (active comparator). Both studies achieved their primary efficacy endpoints, with meaningful improvements in hemoglobin from baseline to the 35 day endpoint of the studies.
Feraheme is indicated for the treatment of IDA in adult chronic kidney disease patients.
For more information call (617) 498-3300 or visit www.amagpharma.com.