AMAG Pharmaceuticals, Inc.
) received a huge blow when the U.S. Food and Drug Administration
(FDA) declined to approve the company's supplemental new drug
application (sNDA) for Feraheme in the present form and issued a
complete response letter (CRL). AMAG's shares skid more than 4.5%
on the news.
AMAG is looking to get Feraheme's label expanded as an
intravenous (IV) use for the treatment of iron deficiency anemia
(IDA) in all adults suffering from chronic kidney disease (CKD)
with a history of unsuccessful oral iron therapy.
The FDA, while issuing the CRL stated that the information
provided by AMAG was insufficient to support the approval of the
additional indication. The U.S. regulatory body has asked AMAG to
conduct additional clinical trials for the broader indication.
The primary composite safety endpoints of these trials should be
serious hypersensitivity/anaphylaxis, cardiovascular events and
Moreover, the FDA recommended the company to evaluate
alternative dosing and/or administration of Feraheme. AMAG
intends to work closely with the FDA to decide on the future
course of action.
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We are extremely disappointed with the news. The CRL will further
delay the approval of Feraheme in the broader indication.
Moreover, conducting additional trials will lead to a surge in
the company's operating expenses. We expect investor focus to
stay on how the company deals with the setback.
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. AMAG is expecting U.S. net
Feraheme product revenues of $71−$71.5 million for the year 2013
compared with $58.3 million in 2012. The company intends to
report its fourth quarter and full year 2013 results in mid-Feb
AMAG currently carries a Zacks Rank #4 (Sell). Some better-ranked
). All these stocks hold a Zacks Rank #1 (Strong Buy).