SFP versus IV Iron

Virtually all of the nearly 400,000 ESRD patients receiving dialysis in the U.S., and 2 million ESRD patients worldwide, require treatment for anemia. Managing anemia in ESRD patients is necessary and can be improved over current IV iron administration. SFP has been designed to effectively address the current challenges in anemia management by:

• Maintaining hemoglobin (Hgb) levels within a safe range using moderate ESA doses
• Improving response to ESA therapy, while avoiding excessively high doses and potential risks
• Preventing iron from being stored in the liver thereby avoiding liver toxicity
• Reducing current drug administration costs

SFP is intended to deliver iron directly to the bloodstream in small, continuous doses three times per week and is designed to replace the 5-7 mg of iron that is lost during every dialysis treatment. This mode of delivery maintains patient Hgb within a target range resulting in moderate ESA dose and improved ESA response. With current IV iron therapy, iron levels are not always adequate when ESA’s are dosed and therefore greater ESA doses are needed; this is believed to contribute to Hgb variability and related adverse consequences.

SFP’s unique properties enable it to avoid storage in the liver upon dosing. Avoiding iron storage in the liver eliminates liver toxicity associated with current IV iron delivery. It is believed that approximately 50 percent of the IV iron that is dosed to a patient never leaves the liver and over time may cause adverse consequences. (Source: Coyne DW, Kapoian T, Suki W, et al. Ferric gluconate is highly efficacious in anemic hemodialysis patients with high serum ferritin and low transferrin saturation: results of dialysis patients' response to IV iron with elevated ferritin (DRIVE) study. JASN. 2007;18:975-984.)

In addition to the potential to provide significant patient benefit and improved patient outcome, SFP is expected to reduce related healthcare costs considerably. Because SFP is delivered via dialysate, required supplies such as needles and syringes needed for current IV therapy are avoided and nursing time to deliver and manage IV iron is no longer needed. Furthermore, because SFP is designed to continously maintain iron balance, as opposed to IV iron which is dosed infrequently to replenish iron after Hgb has dropped below a certain threshold, ESA dose is expected to be significantly reduced, which should result in considerable savings to the dialysis provider.

In the U.S. approximately $560M per year is spent on IV iron for ESRD patients; $850M globally.