AMAG Pharmaceutical has finally received marketing approval for its anaemia treatment Feraheme after repeated delays since the new drug application was submitted in December 2007.
The US Food and Drug Administration (FDA) had twice requested more information following the application for Feraheme, an injection intended to treat iron deficiency anaemia in adults with chronic kidney disease.
AMAG spokesperson said that the approval was based on safety results from four Phase III studies of patients with chronic kidney disease and iron deficiency anaemia.
“Feraheme significantly increased haemoglobin levels as compared to oral iron across the spectrum of chronic kidney disease,” the spokesperson said.
Three studies showed a statistically significant change in haemoglobin from baseline at day 35 after the first dose.
The product is expected to reach shelves in late July 2009.