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FDA ACCEPTS
BAXTER'S NEW DRUG APPLICATION FILING FOR ICODEXTRIN PERITONEAL DIALYSIS
SOLUTION
DEERFIELD, Ill., February
19, 2001 - 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.
Baxter is a leading provider of renal products and services. In 1956,
the company pioneered hemodialysis with the introduction of the first
widely available artificial kidney machine. Nearly 20 years later, Baxter
was one of the first companies to introduce PD. The company is also a
leader in an ultimate solution to kidney failure - transplantation. Baxter
is conducting research in xenotransplantation, or animal-to-human transplants.
Baxter International Inc. (NYSE:BAX) is a global medical products and
services company that provides critical therapies for people with life-threatening
conditions. Baxter's products and services in bioscience (biopharmaceuticals
and blood collection, separation and storage devices), medication delivery
and renal therapy are used by health-care providers and their patients
in more than 100 countries.
FOR ADDITIONAL
INFORMATION:
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- Media Contacts:
- Tanya Olson-Tyska,
(847) 948-3256
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