AMAG Pharmaceuticals, Inc. (AMAG) recently announced that its supplemental new drug application (sNDA) for Feraheme (ferumoxytol) has been accepted by the US Food and Drug Administration (:FDA).
AMAG is looking to get Feraheme’s label expanded for the treatment of chronic kidney disease (:CKD) adults suffering from iron deficiency anemia (IDA) with a history of unsuccessful oral iron therapy. The FDA is expected to render a final decision on the proposed label expansion by Oct 21, 2013.
The company had submitted the regulatory application in Dec 2012 based on data from two phase III trials (IDA-301 and IDA-302). Both studies were successful in achieving their primary objective of meaningful improvements in hemoglobin from baseline.
We note that Feraheme is already approved in the US as an IV iron therapy to treat IDA in adults suffering from CKD. In Nov 2012, AMAG’s European partner Takeda Pharmaceutical (TKPYY) launched the drug for the same indication in the EU under the trade name, Rienso. Rienso is also approved and launched in Canada where it is marketed by Takeda.
AMAG recorded Feraheme net sales of $58.3 million in 2012, up 11.9% from the 2011. We believe that successful label expansion of the drug will drive revenues further. We expect investor focus to remain on Feraheme’s performance in the US as well as the EU.
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