Baxter Healthcare Corporation reported that the Cardiovascular and Renal Drugs Advisory Committee to the U.S. Food and Drug Administration (FDA) unanimously recommended approval of Extraneal (7.5 per cent icodextrin), a peritoneal dialysis (PD) solution. If approved by the FDA, Extraneal would be the first solution with a new osmotic agent introduced for PD patients since 1978 in the United States.
Several members of the advisory panel requested that Baxter conduct additional analyses of the existing database in relation to possible blood pressure effects. Further, the panel recommended that Baxter confer with the FDA to determine if any post-marketing evaluations may be needed. The FDA seeks expert advice from advisory committees as part of its review of a New Drug Application (NDA). However, the final decision regarding the approval of an NDA is made by the FDA.
Baxter is seeking FDA approval of its new PD solution, which is uniquely suited to increase ultrafiltration during the long dwell dialysis exchanges. Dwell is the amount of time dialysis solution remains in the abdominal cavity during PD therapy, which is usually performed in the home.
Current dialysis solutions available in the United States use glucose as the osmotic agent, which acts as the driving force in the removal of fluids. Because Extraneal uses a novel osmotic agent, which is a polymer of glucose, it removes fluid more consistently and in greater amounts over the long dwell as compared to the currently available 1.5% and 2.5% glucose-based solutions.
Ultrafiltration is the removal of fluid from the bloodstream during dialysis. During long dwell dialysis exchanges with currently available solutions, more dialysis fluid may be absorbed into the blood stream than is removed by ultrafiltration, which translates into less effective fluid removal. Effective fluid management is a primary goal of PD according to ultrafiltration management guidelines released this year 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.
Extraneal solution was granted Orphan Drug status by the FDA in 1997, and an NDA was filed with the FDA earlier this year. Extraneal solution is currently approved for marketing in 31 countries, and more than 8,000 patients are currently using the solution worldwide. In Europe, more than 7,000 patients, or nearly 30 percent of the total European PD patient population, currently use the product, which has been available for approximately nine years.
Extraneal solution is contraindicated in patients with a known allergy to cornstarch or icodextrin or in patients with glycogen storage disease. In the clinical trials comparing Extraneal to glucose-based solutions, the most frequent Extraneal treatment-related adverse event was skin rash. Most cases of rash were mild to moderate and all cases completely resolved.
Peritoneal dialysis, which is a form of dialysis performed in a patient's home, 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 process of 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.