AMAG Pharmaceuticals, Inc.
) 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
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
) 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
AMAG currently carries a Zacks Rank #3 (Hold). Other stocks
) currently look more attractive in the pharma space carrying a
Zacks Rank #2 (Buy).
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