FDA APPROVES EXTRANEAL (ICODEXTRIN), BAXTER'S NEW
PERITONEAL DIALYSIS SOLUTION
EXTRANEAL Expands Options for Effective Fluid Management-A Primary
Goal for Home-based Peritoneal Dialysis
First Solution with New Class of Osmotic Agent in United States
DEERFIELD, Ill., December
23, 2002 -- Baxter Healthcare Corporation announced today that the U.S.
Food and Drug Administration (FDA) has approved EXTRANEAL (icodextrin),
a peritoneal dialysis (PD) solution. This solution offers the potential
for increased removal of fluid from the blood stream during dialysis (known
as ultrafiltration) over currently available 1.5% and 2.5% dextrose solutions
during long dwell dialysis exchanges. EXTRANEAL is the first solution
with a new class of osmotic agent introduced for PD patients in the United
States.
"I am excited
about the FDA's approval of EXTRANEAL, which gives physicians a new approach
to addressing fluid management issues for numerous peritoneal dialysis
patients in the United States," said John Burkart, M.D., Professor
of Internal Medicine and Director of Outpatient Dialysis, Nephrology Division
at Wake Forest University School of Medicine, North Carolina. "Effective
fluid management or ultrafiltration is a primary goal of PD therapy, and
now with the introduction of EXTRANEAL, we can help to optimize the treatment
in a new way for our patients."
EXTRANEAL is indicated
for a single daily exchange for the long dwell (8- to 16-hours) during
continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal
dialysis (APD) for the management of chronic renal failure.
"Dwell"
is the amount of time dialysis solution remains in the abdominal cavity
during PD therapy, which is usually performed in the home. "Exchange"
refers to the process of discarding used dialysis solution and instilling
fresh dialysis solution into the abdominal cavity. Ultrafiltration is
the removal of fluid from the bloodstream during dialysis.
Prior to EXTRANEAL,
dialysis solutions available in the United States used glucose as the
osmotic agent, which acts as the driving force in the removal of fluids.
EXTRANEAL solution uses a novel osmotic agent, which is a polymer of glucose,
to remove greater amounts of fluid over the long dwell period as compared
to standard 1.5% and 2.5% dextrose solutions. During long dwell dialysis
exchanges with prior solutions, more dialysis fluid may be absorbed into
the blood stream than is removed by ultrafiltration, which translates
into less effective fluid removal. Fluid removal is a cornerstone of dialysis
therapy, since the patient's native kidneys have limited, if any, residual
ability to eliminate excess fluid from the bloodstream.
Clinical Trial
Results
EXTRANEAL has demonstrated efficacy as a PD solution in clinical trials
of approximately 400 end-stage renal disease (ESRD) patients. Active controlled
trials of one to six months in duration show that EXTRANEAL, used once
daily for the long dwell in either CAPD or APD, resulted in higher net
ultrafiltration compared with 1.5% and 2.5% dextrose solutions, and resulted
in higher creatinine and urea nitrogen clearances compared with 2.5% dextrose
solution. In a single study, ultrafiltration results with 4.25% dextrose
were similar to EXTRANEAL.
"Net ultrafiltration"
is an important measure of dialysis efficacy, which is calculated from
the difference between the volume of solution infused at the start of
the dwell period and the volume drained at its end. "Clearance"
refers to the rate at which a given substance is removed from blood and
is defined as the number of milliliters of blood that would be completely
cleared of a given solute in a pre-determined time period.
EXTRANEAL is currently
approved for marketing in 34 countries, and more than 9,000 patients are
currently using the solution worldwide. The solution is expected to be
available in the first quarter of 2003 in the United States.
"EXTRANEAL solution
improves and expands upon peritoneal dialysis solution options for fluid
management in the United States," said William F. Owen, Jr., M.D.,
chief scientist, Renal Division, Baxter Healthcare Corporation. "EXTRANEAL
represents a significant achievement in our continued effort to develop
innovative therapies for people with kidney disease."
EXTRANEAL is contraindicated
in patients with a known allergy to cornstarch or icodextrin or in patients
with glycogen storage disease. In clinical trials the most frequently
reported adverse events occurring in >10% of patients, and more
common in EXTRANEAL patients than in control patients, were peritonitis,
upper respiratory infection, hypertension and rash. These were also observed
in control patients. The most common treatment-related adverse event for
EXTRANEAL patients was skin rash. Since falsely elevated glucose levels
have been observed with blood glucose monitoring devices and test strips
that use glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ)-based
methods, these should not be used to measure glucose levels in patients
administered EXTRANEAL. Patients with insulin-dependent diabetes may require
modification of insulin dosage following initiation of treatment. For
more information on EXTRANEAL, including prescribing information, view
the package insert information.
(Acrobat
PDF)
ESRD and Treatment
Background
In chronic kidney disease or ESRD, the kidneys are irreversibly destroyed
by disease and can no longer effectively fulfill their role of filtering
and removing wastes, toxins and fluid from the body. In PD, which is one
form of dialysis, extra fluids and waste are removed from the blood inside
the body, using the body's own peritoneal membrane, or abdominal lining,
as a natural filter. This membrane lines the area that holds the stomach,
spleen, liver and intestines. In this form of dialysis, blood never leaves
the body. Dialysis fluid enters the peritoneal cavity through a flexible
catheter surgically inserted in the abdomen. Extra fluid and waste travel
across the peritoneal membrane into the dialysis fluid, which is then
drained from the abdomen through the catheter after a pre-determined dwell
period.
There are two types
of peritoneal dialysis-APD and CAPD. APD is performed using a machine
(cycler) for instillation and drainage of the dialysis solution, and CAPD
is performed by the person using a gravity-based technique instead of
using a machine.
A person performing
PD will typically undergo four to six exchanges daily, of which one is
usually a long-dwell exchange.
In the United States,
more than 300,000 people, or just over one in 1,000 people, are being
treated for ESRD. The number of people being treated for ESRD in the United
States is growing approximately five to six percent annually. Of the estimated
one million people worldwide suffering from ESRD who are treated with
some form of dialysis therapy, 10 to 15 percent use peritoneal dialysis.
Baxter is a leading
global manufacturer of a complete and complimentary portfolio of dialysis-related
products and services designed to assist patients with kidney disease
throughout the continuum of their care. For nearly 50 years, Baxter has
been at the forefront of innovation in kidney care. In 1956, the company
introduced the first disposable coil dialyzer, a development that greatly
enhanced the use and application of hemodialysis. Years later, Baxter
was the first company to introduce peritoneal dialysis products, and the
company continues to introduce new products and services to help enhance
the care of people with kidney disease around the world.
Baxter Healthcare
Corporation is the principal domestic operating subsidiary of Baxter International
Inc., (NYSE: BAX), a global health care company that, through its subsidiaries,
provides critical therapies for people with life-threatening conditions.
Baxter's bioscience, medication delivery and renal products and services
are used to treat patients with some of the most challenging medical conditions,
including cancer, hemophilia, immune deficiencies, infectious diseases,
kidney disease and trauma.
(Baxter and EXTRANEAL
are trademarks of Baxter International Inc. and its affiliates.)
This news release
contains forward-looking statements that involve risks and uncertainties,
including technological advances in the medical field, product demand
and market acceptance, actions of regulatory bodies, the impact of competitive
products and pricing, and other risks detailed in the company's filings
with the Securities and Exchange Commission. These forward-looking statements
are based on estimates and assumptions made by management of the company
and are believed to be reasonable, though are inherently uncertain and
difficult to predict. Actual results or experience could differ materially
from the forward-looking statements.
FOR ADDITIONAL
INFORMATION:
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