Genzyme Corp.
(Nasdaq: GENZ) announced today that a recently completed study of
Renvela(TM) (sevelamer carbonate) achieved its primary endpoint,
demonstrating a statistically significant reduction in serum phosphorus for
hyperphosphatemic patients with chronic kidney disease who are not on
dialysis.
Patients treated with Renvela also achieved a significant reduction in
calcium-phosphorus product and in LDL cholesterol. The drug was well
tolerated with a safety profile consistent with the clinical experience of
patients on dialysis using Renagel(R) (sevelamer hydrochloride). The
multi-center, single arm, open-label trial involved 49 patients at multiple
study sites throughout Europe and Australia.
Full data will be presented at a future medical conference.
Renvela is a buffered form of Renagel, the most-prescribed phosphate
binder in the United States. Like Renagel, Renvela is a calcium-free,
metal- free, non-absorbed phosphate binder and will initially be available
as 800mg tablets once approved.
The results announced today represent one portion of a comprehensive
clinical program for sevelamer carbonate. Data showing the equivalence of
sevelamer carbonate and sevelamer hydrochloride were presented last week at
the spring clinical meeting of the National Kidney Foundation. In addition,
enrollment is complete in two studies comparing a powder form of sevelamer
carbonate to Renagel tablets dosed three times per day, including one study
in which the powder form is dosed three times per day, and one in which it
is dosed once per day.
A New Drug Application for Renvela is currently under review by the US
Food and Drug Administration for the control of serum phosphorus in
patients with chronic kidney disease on dialysis.
About Renagel
Renagel controls serum phosphorus in patients with CKD on hemodialysis.
Controlling serum phosphorus is an important element in the care of
hemodialysis patients. Elevated serum phosphorus levels are common in
dialysis patients and associated with increased risk of cardiovascular
mortality. Renagel provides the added benefit of significant LDL
cholesterol reduction (32 percent).
The National Kidney Foundation's 2003 K/DOQI guidelines for Bone
Metabolism and Disease in Chronic Kidney Disease recommend sevelamer
hydrochloride as a first-line treatment option to control phosphorus.
Renagel is the only phosphate binder available that does not contain either
calcium or a metal. It has an established safety profile, is not
systemically absorbed and provides phosphorus control without the concerns
of calcium or metal accumulation. Renagel is used by more than 350,000
people worldwide.
Product Information
Renagel is indicated for the control of serum phosphorus in patients
with chronic kidney disease (CKD) on hemodialysis. Renagel is
contraindicated in patients with hypophosphatemia or bowel obstruction. In
a 52-week study, the most common side effects included vomiting, nausea,
diarrhea, and dyspepsia. Drug-drug interactions may occur with some
medications and should be taken into consideration when instructing
patients how to take Renagel.
For more information about Renagel, including complete prescribing
information, please visit renagel.
About Genzyme
One of the world's leading biotechnology companies, Genzyme is
dedicated to making a major positive impact on the lives of people with
serious diseases. Since 1981, the company has grown from a small start-up
to a diversified enterprise with more than 9,000 employees in locations
spanning the globe and 2006 revenues of $3.2 billion. Genzyme has been
selected by FORTUNE as one of the "100 Best Companies to Work for" in the
United States.
With many established products and services helping patients in nearly
90 countries, Genzyme is a leader in the effort to develop and apply the
most advanced technologies in the life sciences. The company's products and
services are focused on rare inherited disorders, kidney disease,
orthopaedics, cancer, transplant, and diagnostic testing. Genzyme's
commitment to innovation continues today with a substantial development
program focused on these fields, as well as immune disease, infectious
disease, and other areas of unmet medical need.
Genzyme(R) and Renagel(R) are registered trademarks and Renvela(TM) is
a trademark of Genzyme Corporation. All rights reserved.
Genzyme Corp.
genzyme
View drug information on RenaGel.
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