) share price dropped 14.3% on Sep 25, 2013 to close the trading
session at $22.42. The share price of the company was negatively
affected following a notification from the U.S. Food and Drug
Administration regarding the supplemental New Drug Application
(sNDA) of Feraheme.
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AMAG is looking to get Feraheme's label expanded for the
treatment of iron deficiency anemia (IDA) in patients suffering
from chronic kidney disease (CKD) with a history of unsuccessful
oral iron therapy.
The FDA stated in its notification that it has identified some
shortcomings while reviewing the application which have stopped
discussion regarding labelling and post-marketing
requirements/commitments. However, the FDA said that its
notification does not reflect a final decision on the information
under review. The company mentioned that it will be working with
the U.S. regulatory authorities to resolve this issue.
Technical and scientific information, labelling, post-marketing
requirements/commitments, risk evaluation and mitigation
strategies related to CKD and proposed IDA populations, new
studies or re-analyses of existing data are some of the topics
that are expected to be discussed with the FDA.
In Dec 2012, AMAG submitted the sNDA for Feraheme for the
treatment of CKD adults suffering from IDA with a history of
unsuccessful oral iron therapy. The U.S. regulatory body is
expected to render a final decision on the proposed label
expansion by Oct 21, 2013. We expect investor focus to remain on
the final decision of the FDA.
AMAG has an agreement with
) for Feraheme, in the EU and Canada. During the second quarter
of 2013, Takeda also filed a regulatory application with the
European Medicines Agency to expand Rienso's (EU trade name of
Feraheme) to include treatment of IDA in all adults who have a
history of unsatisfactory oral iron therapy or who cannot
tolerate or do not respond to such treatment.
Feraheme is currently approved as an injectable drug for
intravenous use as iron replacement therapy for the treatment of
IDA in adults suffering from CKD. In the second quarter of 2013,
U.S. net sales of Feraheme amounted to $17.5 million, up 29% year
AMAG currently carries a Zacks Rank #3 (Hold). Meanwhile, other
stocks such as
) look more attractive in the pharma space. While Actelion
carries a Zacks Rank #1 (Strong Buy), Athersys carries a Zacks
Rank #2 (Buy).