Lexington, MA-based AMAG Pharmaceuticals said today that 146 cases of serious adverse events have been reported in patients taking Feraheme, a recently-approved drug for iron deficiency anemia in chronic kidney disease patients. Worse, life-threatening and fatal events, including hypersensitivity and cardiac events, have been reported after Feraheme administration. The company says its in dicussions with the FDA concerning label changes. AMAG's stock dropped 25 percent on the announcement.
Declining sales of the drug have forced the developer to cut its staff by 24 percent. "As our sales in the dialysis segment have begun to decline at a rate quicker than our growth in the non-dialysis chronic kidney disease (CKD) segment, we have made the difficult decision to restructure our organization," said Brian J.G. Pereira, M.D., president and chief executive officer of AMAG. "...[We] are reducing staff and operating expenses to optimize our use of capital and ensure that we invest wisely for the future of Feraheme and AMAG." The company will incur $2.7 million in charges associated with the restructuring,
- take a look at AMAG's release
- read the Reuters report