Shares of Amag Pharmaceuticals Inc. soared by 13% on Monday after the drugmaker said it reached an agreement with regulators on an updated product label for the anemia drug Feraheme.
The company said the updated label it agreed to with the Food and Drug Administration(FDA) does not include a boxed warning. But, it does include bolded warnings for problems that have been reported after the intravenous injection is administered. That includes life-threatening hypersensitivity reactions and clinically significant hypotension.
The updated product label also includes an increased observation period to 60 minutes from 30 minutes to observe patients for signs of hypersensitivity.
Amag CEO Dr. Brian J.G. Pereira said in a statement from the company they were pleased to put to put the uncertainty behind them.
A Brief History: Amag said late last month it would slash 24 percent of its work force due to declining sales and safety concerns surrounding Feraheme, its only marketed product. Sales of Feraheme fell on a quarter-to-quarter basis because of a decline in provider demand in the dialysis market. Demand also fell in the non-dialysis market because of safety concerns.
Feraheme is approved for the treatment of iron deficiency anemia in adult patients with chronic kidney disease.
AMAG Pharmaceuticals, Inc., a biopharmaceutical company, engages in the development and commercialization of therapeutic iron compounds to treat iron deficiency anemia (IDA) in the United States, Europe, and Japan. It also provides novel imaging agents to aid in the diagnosis of cancer and cardiovascular diseases. It offers Feraheme, an iron replacement therapeutic for the treatment of IDA in adult patients with chronic kidney disease; and GastroMARK used for delineating the bowel in magnetic resonance imaging (MRI). The company is also developing Feraheme, which is in Phase II clinical trials for use as a vascular-enhanced MRI agent for the assessment of peripheral arterial disease. AMAG Pharmaceuticals has collaborative agreements with 3SBio Inc. for the development and commercialization of Feraheme as an IV iron replacement therapeutic agent in China; Guerbet S.A; Takeda Pharmaceutical Co. Ltd.; and Covidien for marketing GastroMARK in the United States, Canada, and Mexico. The company was founded in 1981 and is based in Lexington, Massachusetts.