FDA Approves Oral Chelator Ferriprox
October 14, 2011 – The Cooley’s Anemia Foundation (CAF) applauds a Food and Drug Administration (FDA) decision today to approve the new drug application for the oral chelator, Ferriprox. This action follows a 10-2 vote on September 14, 2011 by the Oncology Drugs Advisory Committee to recommend the approval of this drug.
“As the premier voice of the thalassemia community in the United States, we are thrilled that our patients will have the benefit of this drug which has proven beneficial to patients throughout the world,” says CAF National President Anthony J. Viola. “The FDA clearly responded to the overwhelming need for this drug in our patient population and has provided those patients needing daily drug therapy to remove iron, an option that has improved cardiac health and prolonged life in thousands of patents over the past decade.”
Ferriprox is an oral chelator. In addition to being easier to administer than Desferal, Studies published in Europe demonstrate that use of Ferriprox has been shown to protect the heart from iron accumulation, a crucial concern for individuals with thalassemia.
“The major cause of death in our patient population is iron-related heart failure,” says Viola. “And with a very significant percentage of our population unable to use either Desferal or Exjade, there is a vital need for another option; that option is Ferriprox.”
The Foundation believes that patients need as many treatment options as possible and welcomes the addition of Ferriprox and future chelators to the menu of options. CAF has been monitoring the success of Ferriprox in other countries for more than a decade and has made sure that the patient need for more options was recognized by the FDA.
“We have seen too many patients die too young,” Viola concludes. “Our patients’ lives depend upon having more treatment options available to them. The FDA addressed the unmet medical needs of these desperately ill patients and provided approval for a drug that will help them. Their decision has the opportunity to extend our patient’s lives and significantly improve their quality of life.”
Click here to read more about the decision to approve Ferriprox.