The US Food and Drug Administration has issued a stamp of approval for Rockwell Medical’s iron replacement therapy Triferic.
Specifically, the drug has been cleared to maintain haemoglobin levels in adult patients with haemodialysis-dependent chronic kidney disease.
According to Rockwell’s founder and chief executive Robert Chioini, Triferic is “the first drug approved to replace ongoing iron losses and to maintain haemoglobin levels in haemodialysis patients”, and he stressed that its “unique ability” to be delivered via dialysate without increasing iron stores could see it become a market leader.
An FDA advisory panel backed the drug’s approval last November.
