AMAG Pharmaceuticals’ (AMAG) 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.
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 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 #3 (Hold). Meanwhile, other stocks such as Actelion Ltd. (ALIOF) and Athersys, Inc. (ATHX) look more attractive in the pharma space. While Actelion carries a Zacks Rank #1 (Strong Buy), Athersys carries a Zacks Rank #2 (Buy).