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FDA Delays Verdict for AMAG's Feraheme - Analyst Blog

Posted
10/17/2013 5:00:00 PM
By: Zacks.com
Referenced Stocks:ALIOF;AMAG;IDA;ISIS;TKPYY

AMAG Pharmaceuticals ( AMAG ) announced that the U.S. Food and Drug Administration (FDA) has pushed back the originally assigned target date for Feraheme by three months.

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 under review.

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 Takeda Pharmaceuticals ( TKPYY ) 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 over year.

AMAG currently carries a Zacks Rank #1 (Strong Buy). Other stocks such as Actelion Ltd. ( ALIOF ) and Isis Pharmaceuticals, Inc. ( ISIS ) also carry a comparable bullish rank.



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