Abbott Laboratories' Zemplar(R) (Paricalcitol Injection) Receives FDA Approval for Pediatric Use
27 Maggio 2004 - 4:30PM
PR Newswire (US)
Abbott Laboratories' Zemplar(R) (Paricalcitol Injection) Receives
FDA Approval for Pediatric Use - Third-Generation Vitamin D
Compound Offers Young Dialysis Patients A New Treatment for
Secondary Hyperparathyroidism Associated with Kidney Disease -
ABBOTT PARK, Ill., May 27 /PRNewswire-FirstCall/ -- Abbott
Laboratories announced that the U.S. Food and Drug Administration
(FDA) has approved Zemplar(R) (paricalcitol injection) for use in
children and adolescent hemodialysis patients, ages 5 to 19, with
secondary hyperparathyroidism (SHPT). Zemplar initially was
introduced in 1998 and currently is used to treat SHPT in the
majority of adult dialysis patients in the United States. Patients
with kidney failure are unable to produce the active form of
vitamin D. As a result, many dialysis patients have vitamin D
deficiency and develop SHPT, a disorder that causes bone disease
and can affect many organs and tissues, including the bones, red
blood cells, heart, nerves and muscles. "Because of the unique
characteristics of the growing skeleton, children are particularly
vulnerable to the complications of kidney failure and secondary
hyperparathyroidism that can lead to bone deformities and growth
retardation," said Isidro B. Salusky, M.D., a pediatric
nephrologist and professor of pediatrics at the David Geffen School
of Medicine at the University of California at Los Angeles, and the
lead investigator for the clinical research and data collection
used to support Abbott's application to the FDA seeking expanded
use of Zemplar. "We need to know that the therapies available for
adults are also safe for children -- and now we do. This new
information allows us to feel comfortable giving children the same
therapy prescribed for adult patients." Approximately 1,400
American children between the ages of 5 and 19 undergo
hemodialysis, a time-consuming treatment in which blood is filtered
through an artificial kidney machine to remove wastes and extra
fluid from the blood. Kidneys help keep bones healthy by
metabolizing vitamin D, converting it into the active D compound
that helps regulate parathyroid hormone (PTH) secretion and bone
metabolism, as well as calcium and phosphorus levels. In the
absence of active vitamin D, many patients with kidney failure
develop SHPT, where the parathyroid glands produce excess amounts
of PTH. Without proper management, SHPT can lead to weak and
brittle bones, anemia, and cardiac and neurological problems.
Because bones and other organs are still developing in children,
and because they are typically patients for longer periods of time,
complications related to SHPT can be more difficult to treat than
in adults. Left untreated, SHPT can be a factor in growth
retardation and lead to severe disability. "I have witnessed the
toll of kidney disease and dialysis on younger patients and their
families," said Joel Melnick, M.D., global medical director, Abbott
Laboratories, and a pediatric nephrologist. "One of the reasons
that controlling secondary hyperparathyroidism in children is
especially challenging is that their diets frequently may be high
in phosphorous, the control of which is critical in dialysis
patients. A third-generation D compound like Zemplar that did not
cause hyperphosphatemia and hypercalcemia in clinical studies is an
incredibly important asset for younger patients and can help them
lead more normal lives." "Approval of Zemplar for use in pediatric
patients demonstrates Abbott's commitment to addressing the needs
of the wide range of patients with kidney disease," said William
Dempsey, senior vice president, Pharmaceutical Operations, Abbott
Laboratories. "Abbott recently launched a worldwide research
program to further study D-Receptor activation in chronic kidney
disease and for a variety of related disorders." Zemplar Pediatric
Study Results The safety and effectiveness of Zemplar were examined
in a 12-week randomized, double-blind, placebo-controlled study of
29 pediatric patients, ages 5 to 19 years, with chronic renal
failure on hemodialysis. Nearly all had received some form of
vitamin D therapy prior to the study. Sixty percent of patients in
the Zemplar group had two consecutive 30 percent decreases in
parathyroid hormone levels compared with only 21 percent of
patients in the placebo group. Fewer Zemplar patients than placebo
patients (23 percent compared to 31 percent) experienced elevated
serum calcium levels. The overall percentage of serum calcium
measurements (defined as 10.3 mg/dL or greater) was 7 percent in
the Zemplar group and 7 percent in the placebo group. No subjects
in either the Zemplar group or placebo group developed
hypercalcemia (defined as at least one calcium value >11.2
mg/dL) during the study. Another side effect measurement used in
the study was the product of serum calcium and phosphorus levels
(Ca x P), measured in terms of mg(2)/dL(2). In this study, 40
percent of Zemplar patients, compared to 14 percent of placebo
patients, had at least one Ca x P > 72. The overall percentage
of patients with Ca x P > 72, however, was 8 percent in the
Zemplar group and 7 percent in the placebo group. About Children
and Kidney Failure According to the National Institute of Diabetes
and Digestive and Kidney Disease (NIDDK) at the National Institutes
of Health (NIH), of every 100,000 children 19 and under, one or two
will develop kidney failure each year. African-American teenagers
are three times more likely than white teens to develop kidney
failure, and boys are twice as likely as girls to develop kidney
failure due to birth defects or other hereditary conditions.
Because poorly functioning kidneys can leave the body's vitamin and
mineral resources out of balance, the National Kidney Foundation
notes that children with kidney disease are at risk for stunted
growth and poor bone density. Product Indications Zemplar(R)
(paricalcitol injection) is indicated for the prevention and
treatment of secondary hyperparathyroidism associated with chronic
renal failure. Important Product Safety Considerations As observed
in Phase II and III clinical trials, adverse effects with greater
than 5 percent frequency with Zemplar versus placebo, regardless of
causality, were nausea (13 percent versus 8 percent), vomiting (8
percent versus 4 percent), and edema (7 percent versus 0 percent).
Zemplar is contraindicated in patients with vitamin D toxicity,
hypercalcemia, or hypersensitivity to product ingredients.
Administration may place patients at risk for hypercalcemia,
elevated Ca x P product, and metastatic calcification. For full
prescribing information on Zemplar visit
http://www.abbottrenalcare.com/ . Abbott and Chronic Kidney Disease
Abbott is committed to ongoing innovation in the area of chronic
kidney disease and related complications. In November 2003, Abbott
launched a multi-million dollar global research effort to study the
effects of D-Receptor activation in patients with chronic kidney
disease (CKD). The program will involve a number of pre-clinical
and clinical studies. Abbott is investigating the use of an oral
formulation of Zemplar for the treatment of SHPT in pre-dialysis
CKD patients. Recently completed, these global, multi-center trials
are the largest studies ever conducted in pre- dialysis CKD
patients with SHPT. Abbott expects to submit a New Drug Application
with the FDA in the second half of 2004. About Abbott Abbott
Laboratories is a global, broad-based health care company devoted
to the discovery, development, manufacture and marketing of
pharmaceuticals and medical products, including nutritionals,
devices and diagnostics. The company employs more than 55,000
people and markets its products in more than 130 countries.
Abbott's news releases and other information are available on the
company's Web site at http://www.abbott.com/ . DATASOURCE: Abbott
Laboratories CONTACT: Media, Laureen Cassidy, +1-847-938-7743;
Financial Community, John Thomas, +1-847-938-2655, both of Abbott
Laboratories Web site: http://www.abbott.com/ Company News On-Call:
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