Shares of Amag Pharmaceuticals Inc. soared Monday after the drugmaker said it reached an agreement with regulators on an updated product label for the anemia drug Feraheme.
THE SPARK: The Lexington, Mass., company said the updated label it agreed to with the Food and Drug Administration does not include a boxed warning.
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.
THE BACKGROUND: 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.
SHARE ACTION: Up 15 percent, or $2.11, to $16.20 in Monday morning trading, while broader trading indexes fell about 1 percent.