Rockwell Medical completed a second late-stage study in September (the earlier, identical late-stage trial ended in July) and announced that its experimental drug has met the main goal of improving hemoglobin levels in adult patients with chronic kidney disease, Reuters reported.
Carol Werther, a Summer Street research analyst, said that the company will be able to file for marketing approval in 6 months or less. She noted that soluble ferric pyrophosphate (SPF) perhaps could be approved in the second half of 2014. Werther predicted that the drug could generate annual sales of $225 million in 2017.
The administration of SFP is different from that of conventional iron therapies for dialysis patients who need iron. SFP is given along with the fluid used in dialysis, whereas the standard care is to give iron therapy intravenously to patients with chronic kidney disease.
Summer Street’s Werther said that the drug’s unique method of administration allows for maintenance of hemoglobin levels and lowers the risk of iron overload, which could increase infection rates in patients receiving dialysis. Patients lose several milligrams of iron during a dialysis treatment.
The company reported positive results from the first study of SFP in July.
A separate study in February showed that regular treatment with the drug reduced the need for erythropoiesis-stimulating agents.
Chief Executive Officer Rob Chioini said that he has great confidence in getting approval from the U.S. Food and Drug Administration for the drug and that “SFP could become the new standard of care in iron therapy,” Reuters reported.
