Label Update for AMAG's Feraheme
Zacks Equity Research, On Friday June 24, 2011, 6:10 pm EDT
AMAG Pharmaceuticals Inc. (NasdaqGS: AMAG - News) recently announced a label update for its lead drug Feraheme. Feraheme is an injectable drug for intravenous use as an iron replacement therapy for the treatment of iron deficiency anemia (IDA) in adult patients suffering from chronic kidney disease (CKD).
The label was updated following approval by the US Food and Drug Administration (FDA) of the company's Label Supplement submission which included additional post-marketing safety data.
AMAG modified its Warnings and Precautions section to revise the language used to describe the hypersensitivity reactions. The revised label mentions that fatal and life-threatening serious hypersensitivity reactions, including anaphylactic-type reactions, have been reported in patients who have received Feraheme.
The Contraindications section was also modified to remove language relating to evidence of iron overload and anemia not caused by iron deficiency. Finally the observation time of the patients for signs and symptoms of hypersensitivity following administration of Feraheme was decreased to 30 minutes from 60 minutes.
The observation time was earlier increased from 30 minutes to 60 minutes during a previous label update in November 2010. The label was also updated in November to describe events like life-threatening hypersensitivity reactions and clinically significant hypotension that have been reported following administration of Feraheme in the post-marketing environment.
The company had then inserted a new section to the label entitled Adverse Reactions from Post-Marketing Spontaneous Reports. Importantly, the FDA did not require the inclusion of a black box warning.
We believe that the decrease in observation period is a positive development, which combined with the faster dosing schedule of Feraheme, will help differentiate the drug from other competing therapies in the market. Feraheme competes with existing intravenous/IV iron replacement therapies like American Regent Inc.’s Venofer.
Our Recommendation
We currently have a Neutral recommendation on the stock. The recommendation is supported by a Zacks #3 rank (short term “Hold” rating). We prefer to remain on the sidelines until more visibility is obtained on Feraheme’s progress despite the improving monthly trend in provider demand.
surf's up......crikey
