8:49AM AMAG Pharma announces FDA acceptance of supplemental new drug application for Feraheme label expansion to include iron deficiency anemia patients who cannot take oral iron; Both studies achieved their primary efficacy endpoints (AMAG) 17.82 : Co announced that the FDA has accepted for review the company's supplemental new drug application for Feraheme Injection for Intravenous use, which was submitted to the FDA in December 2012. The sNDA requests FDA approval to expand the indication for ferumoxytol beyond the current indication for the treatment of iron deficiency anemia in adult patients with chronic kidney disease to adult patients with IDA who have failed or could not take oral iron treatment. Under the Prescription Drug User Fee Act guidelines, the sNDA is subject to a 10-month review by the FDA. With the acceptance of the submission, the FDA has set October 21, 2013 as a target date for completion of their review.
The sNDA submission is based on data from a global phase III program that evaluated the use of ferumoxytol in a broad range of adult IDA patients, all of whom had failed or could not take oral iron treatment. More than 1,400 patients were enrolled in the two phase III clinical trials, known as IDA-301 and IDA-302. Both studies achieved their primary efficacy endpoints, with statistically significant improvements in hemoglobin from baseline to the 35-day endpoint of the studies. Adverse events and serious adverse events commonly associated with ferumoxytol and other IV iron therapies, including hypersensitivity reactions, were reported in both studies. No new safety signals, outside of those described in the current Feraheme label, were observed with ferumoxytol treatment in these studies.
