AMAG pulled out of a presentation at the UBS 2010 Global Life Sciences Conference, which was scheduled for Sept. 22, due to an upcoming meeting the FDA, according to a Sept. 20 company filing with the U.S. Securities and Exchange Commission (SEC).
The meeting is in regards to “the recent creation of a tracked safety issue” for Feraheme. Specifically, they will discuss potential safety signals of cardiac disorders in patients receiving the iron drug, according to the SEC filing.
The FDA approved Feraheme last year for intravenous use as an iron replacement therapy in the treatment of iron deficiency anemia in adult patients with chronic kidney disease.
Feraheme generated $16 million of the company’s total of $18.4 million in revenue for the second quarter ended June 30.
In February, SummerStreet Research Partners analyst Carol Werther released a research note that said, "We are aware of several patients hospitalized with anaphylactiod reactions (severe allergic reactions) to Feraheme. We are aware of one death that may or may not be directly related to Feraheme."
In a response released in February, AMAG said that since the commercial launch of Feraheme in July 2009, serious adverse events have been reported at a rate consistent with that contained in the U.S. package insert.
Of the estimated 35,000 patient exposures at that time, 40 serious adverse events had been reported, an approximate rate of 0.1 percent, according to AMAG. No mortality signal had been observed.
AMAG said a single reported death occurred in a patient two days post-Feraheme treatment, which the company did not believe was the result of Feraheme.
Feraheme is contraindicated in patients with evidence of iron overload, known hypersensitivity to Feraheme or any of its components, and patients with anemia not caused by iron deficiency.
