Rockwell Wins Approval for Triferic

Rockwell Medical has won drug approval by the US Food and Drug Administration (FDA) for a new anemia drug, Triferic (soluble ferric pyrophosphate or SFP).

The results from two phase 3 clinical studies demonstrated that Triferic was effective in maintaining “hemoglobin during the treatment period in iron-replete patients with hemodialysis-dependent chronic kidney disease in the studies as conducted,” according to FDA documents.

The drug could reduce the need for erythropoiesis-stimulating agents (ESAs). Motley Fool financial website highlighted data that showed a reduction of 30 to 37 percent in the need for ESAs when Triferic was used. “The impact of this on dialysis providers is enormous,” Motley Fool wrote, and estimated that a 35 percent reduction in the $2 billion spent on ESAs annually would be about $700 million in savings.

Several industry analysts expect Triferic to change the way iron replacement therapy is given in dialysis patients. Triferic so far is the only iron replacement therapy that can be delivered through the dialysate solution. Triferic also is slowly infused and taken up by the body in a manner similar to dietary absorption, Seeking Alpha noted, qualities that may be bad news for earlier FDA-approved intravenous iron products for the treatment of iron deficiency anemia that require patient monitoring after administration.