AMAG Pharmaceuticals Inc. (AMAG - Free Report) 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 be used.
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 iron therapy.
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 Takeda Pharmaceutical 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 such as Transcept Pharmaceuticals, Inc. and Shire (SHPG - Free Report) currently look more attractive in the pharma space, carrying a Zacks Rank #1 (Strong Buy) and Zacks Rank #2 (Buy) respectively.