AMAG Pharmaceuticals Inc.
) recently announced positive preliminary results from the
IDA-303 study on Feraheme (ferumoxytol). The IDA-303 study
evaluated the safety and efficacy of Feraheme in patients
suffering from persistent or recurring iron deficiency anemia
(IDA) irrespective of the underlying cause and a history of
unsatisfactory oral iron therapy or in whom oral iron could not
Results from the IDA-303 study showed that patients who
received their first course of therapy showed a statistically
significant increase in hemoglobin from baseline to week five.
The change observed in the study was similar to increase in
hemoglobin reported in both the IDA-301 and IDA-302 studies.
Last week, AMAG had announced that its supplemental new drug
application (sNDA) for Feraheme has been accepted by the US Food
and Drug Administration (FDA). The sNDA was submitted in Dec
2012. 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
The FDA is expected to render a final decision on the proposed
label expansion by Oct 21, 2013.
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 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.
AMAG currently carries a Zacks Rank #3 (Hold). Other stocks
Transcept Pharmaceuticals, Inc.
) currently look more attractive in the pharma space, carrying a
Zacks Rank #1 (Strong Buy) and Zacks Rank #2 (Buy)
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