) announced that the U.S. Food and Drug Administration (FDA) has
pushed back the originally assigned target date for Feraheme by
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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 U.S. regulatory body was expected to
render a final decision on the proposed label expansion by Oct
21, 2013, which has now been postponed to Jan 21, 2014.
Last month AMAG received a notification from the FDA regarding
the supplemental new drug application (sNDA) on Feraheme. The FDA
stated in its notification that it has identified some
shortcomings while reviewing the application which stopped
discussion regarding labelling and post-marketing
requirements/commitments. However, the FDA had said that its
notification does not reflect a final decision on the information
AMAG subsequently met the FDA officials, following which the
company provided additional information to the U.S. regulatory
body. The FDA extended the review period as it needs more time to
review the additional data.
We remind investors that 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. 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 #1 (Strong Buy). Other stocks
Isis Pharmaceuticals, Inc.
) also carry a comparable bullish rank.