FDA Accepts Baxter's New Drug Application Filing for Icodextrin Peritoneal Dialysis Solution
DEERFIELD, Ill., Feb. 19 /PRNewswire/ -- Baxter Healthcare Corporation today announced that its New Drug Application (NDA) for icodextrin 7.5% has been accepted for filing by the U.S. Food and Drug Administration (FDA). The company is seeking approval of its peritoneal dialysis (PD) solution in the United States as an alternative to conventional solutions, with the potential for increased ultrafiltration during long dwell dialysis exchanges. PD is a type of dialysis usually performed in a patient's home.
Ultrafiltration is the ability to remove fluid from the bloodstream during dialysis. During long dwell dialysis exchanges with conventional solutions, more dialysis fluid may be absorbed into the blood stream than is removed by ultrafiltration. Effective fluid management is a primary goal of PD according to ultrafiltration management guidelines ( www.ispd.org/guidelines/articles/pdi20sup4/mujais.php3 ) recently released by the International Society of Peritoneal Dialysis, which recommend, in part, the greater use of dialysis solutions that can optimize fluid management of the PD patient.
Icodextrin is approved for marketing as Extraneal in 28 countries. The solution is being used by more than 6,800 patients worldwide. Outside of the U.S. where the solution is currently marketed, it is recommended as a once daily replacement for a single glucose exchange as part of continuous ambulatory peritoneal dialysis or automated peritoneal dialysis for the treatment of end-stage renal disease (ESRD), particularly for patients who may have decreased ultrafiltration on conventional solutions.
Treatment Options for Kidney Failure
Two treatment options are available to patients with kidney failure resulting in ESRD: transplantation and dialysis (hemodialysis or peritoneal). During hemodialysis, a needle is inserted into a blood vessel in the arm or leg. The blood is then pumped through an artificial kidney machine containing a filtering system called a dialyzer that cleanses the blood and returns the cleansed blood back to the body. Most people undergoing hemodialysis visit a hospital or dialysis center three times a week for a four-hour dialysis session.
Peritoneal dialysis uses the peritoneal membrane as the filter device. To gain access, a catheter is surgically inserted through the wall of the peritoneal cavity into which the dialysis solution is infused. Through the processes of diffusion and osmosis, toxins and excess fluids move across the membrane into the solution. After a predetermined dwell period, the solution is drained from the cavity through the catheter.
More than 300,000 people in the United States, or just over one in 1,000 Americans, are being treated for ESRD, which occurs when the kidneys are destroyed by disease. The number of people being treated for ESRD is growing at about 7 percent annually, and as the number of patients increase, so do the costs for treating the disease. It is estimated that nearly one million people worldwide suffer from ESRD |
