FDA Approves Innovative, First-In-Class Treatment for a Serious Complication of Chronic Kidney Disease
Amgen Introduces Sensipar(TM) Approved to Treat Secondary Hyperparathyroidism
in Dialysis Patients
THOUSAND OAKS, Calif., March 8 -- Amgen Inc.
(Nasdaq: AMGN), the world's largest biotechnology company, today announced
that the U.S. Food and Drug Administration (FDA) approved Sensipar (cinacalcet
HCl) following a priority review. Sensipar, an innovative, first-in-class
oral calcimimetic, is indicated for the treatment of secondary
hyperparathyroidism (secondary HPT) in chronic kidney disease (CKD) patients
on dialysis and the treatment of elevated calcium levels (hypercalcemia) in
patients with parathyroid carcinoma; and has been shown to be safe and
Nearly all of the more than 300,000 dialysis patients in the U.S. suffer
from secondary HPT. The disease can develop early during the course of CKD
and continues to progress as kidney function declines. Untreated secondary
HPT is characterized by abnormal calcium and phosphorus levels and is
associated with serious consequences, including cardiovascular morbidity.
Sensipar meets a significant medical need in patients with secondary HPT.
"It is the only available therapy that allows practitioners to reduce
parathyroid hormone (PTH) while lowering calcium-phosphorus product, which is
consistent with the National Kidney Foundation's Kidney Disease Outcomes
Quality Initiative (K/DOQI) clinical practice guidelines for bone metabolism
and disease in chronic kidney disease," said Beth Seidenberg, M.D., chief
medical officer and senior vice president of global development at Amgen.
The NKF's K/DOQI clinical practice guidelines are a response to the strong
correlation between these biochemical parameters and morbidity and mortality
in the CKD population.
"Amgen is very proud to offer this innovative, safe and effective medicine
to patients and physicians. This major milestone demonstrates Amgen's prowess
to bring efficacious and innovative medicines to market quickly and
efficiently," said Seidenberg.
Secondary HPT is characterized by elevations in PTH, calcium and
phosphorus levels. If left untreated, patients with secondary HPT develop bone
disease, bone pain and fractures, vascular and soft tissue calcifications,
which are frequently associated with an increased risk of hospitalization and
Prior to the approval of Sensipar, the only available medical treatments
for patients with secondary HPT were phosphate binders and vitamin D sterols,
which may elevate calcium and/or phosphorus levels. As a consequence,
treatment is frequently interrupted - resulting in inadequate control of PTH.
Sensipar provides targeted treatment of secondary HPT with its unique
mechanism of action that acts directly on the calcium-sensing receptor, the
primary regulator of PTH.
"With cinacalcet HCl now available, there is no question that there is a
large number of patients who need this therapy right away. We have a lot of
patients whose disease is very poorly controlled and in our attempt to control
their disease, we are producing side effects that are completely
unacceptable," said Geoffrey Block, M.D., a lead investigator for the phase 3
trials and director of clinical research at Denver Nephrologists, PC. "In the
clinical trials I have done with cinacalcet HCl, I have been astounded by how
well this drug can control PTH, lower calcium and lower phosphorus. Patients
for the first time are achieving levels of phosphorus that they recognize will
protect their health over the long term."
Sensipar provides significant improvement over traditional therapy by
bringing multiple parameters into NKF's K/DOQI clinical practice guidelines
recommended target range at the same time.
"Achieving the new K/DOQI guidelines has been challenging with existing
therapies, and has required clinicians to make tough decisions regarding
therapeutic goals," said Brian Pereira, M.D., president and chief executive
officer at the New England Health Care Foundation and professor of medicine at
Tufts-New England Medical Center. "Sensipar gives the nephrology community an
important new tool to help dialysis patients suffering from secondary HPT to
achieve all four therapeutic target goals."
Patients with parathyroid carcinoma have a rare, serious cancer of the
parathyroid gland resulting in excess secretion of PTH, a form of primary HPT.
The disease is complicated by elevated calcium levels in the blood. High
calcium levels can lead to anxiety, depression, nausea, vomiting, bone
fractures, kidney stones and in some cases coma. Surgical removal of the
parathyroid gland is the only curative therapy for this disease but is not
successful in all cases. Sensipar was shown to reduce high levels of calcium
in patients with parathyroid carcinoma. With approximately 500 patients
developing parathyroid carcinoma each year, Sensipar was granted orphan
In clinical trials in patients with secondary hyperparathyroidism on
dialysis, Sensipar was safe and effective in reducing PTH, calcium-phosphorus
product, calcium and phosphorus in a broad range of patients regardless of
age, gender, race, years on dialysis or disease severity. Sensipar was
effective in patients receiving vitamin D, as well as those not receiving
In clinical studies involving more than 1,100 patients, 40 percent of
Sensipar patients and five percent of placebo patients receiving standard of
care achieved PTH levels less than or equal to 250 pg/mL in the primary
efficacy analysis. Secondary efficacy parameters also improved in patients
treated with Sensipar. These studies showed that Sensipar reduced PTH while
lowering calcium-phosphorus product, calcium and phosphorus levels.
Reductions in PTH and calcium-phosphorus product were maintained for up to 12
months of treatment.
In a clinical trial in patients with hypercalcemia due to parathyroid
carcinoma, Sensipar lowered calcium levels.
Based on its mechanism of action, Sensipar lowers calcium, so it should
not be initiated if the calcium level is less than 8.4 mg/dL. During dose
titration, calcium levels should be monitored frequently and if levels
decrease below the normal range, appropriate steps should be taken to increase
calcium levels. The threshold for seizures may be lowered by reductions in
calcium levels and, infrequently, seizures have been reported, primarily in
patients with a seizure history. The most commonly reported side effects are
nausea and vomiting.
Amgen licensed Sensipar from NPS Pharmaceuticals Inc. in 1996. Amgen
applied for regulatory approval in Australia, Canada, the European Union and
Amgen is a global biotechnology company that discovers, develops,
manufactures and markets important human therapeutics based on advances in
cellular and molecular biology.
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This news release contains forward-looking statements that involve
significant risks and uncertainties, including those discussed below and
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2002, and in our periodic reports on Form 10-Q and Form 8-K. Amgen is
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