THOUSAND OAKS, Calif.,
Aug. 24, 2016 /PRNewswire/
-- Amgen (Nasdaq: AMGN) today announced that the U.S. Food and
Drug Administration (FDA) has issued a Complete Response Letter for
the New Drug Application (NDA) for Parsabiv™
(etelcalcetide) for the treatment of secondary hyperparathyroidism
(sHPT) in adult patients with chronic kidney disease (CKD) on
hemodialysis.
Amgen is reviewing the Complete Response Letter, and we
anticipate a post-action meeting with the FDA later this year to
discuss the Complete Response.
The Complete Response Letter does not impact our regulatory
submissions in other regions.
About Secondary Hyperparathyroidism
sHPT is a chronic
and serious condition which affects many of the approximately two
million people throughout the world who are receiving dialysis,
including 468,000 people in the U.S.1-4 Approximately 88
percent of dialysis patients and 79 percent of patients on
hemodialysis will develop sHPT.5 sHPT refers to the
excessive secretion of parathyroid hormone (PTH) by the parathyroid
glands in response to decreased renal function and impaired mineral
metabolism.1 The elevated levels of PTH can lead to an
increase in the release of calcium and phosphorus from the
bones.6 sHPT is often initially silent and asymptomatic.
As a result, sHPT is frequently underdiagnosed and
undertreated.7
About
Parsabiv™ (etelcalcetide)
Parsabiv
is a novel calcimimetic agent under investigation for the treatment
of sHPT in adult CKD patients on hemodialysis and is administered
intravenously at the end of the hemodialysis session. A
calcimimetic is a drug that mimics the action of calcium by
activating the calcium-sensing receptors on the parathyroid gland.
Parsabiv binds to and activates the calcium-sensing receptor on the
parathyroid gland, thereby decreasing PTH levels.
About Amgen
Amgen is committed to unlocking the
potential of biology for patients suffering from serious illnesses
by discovering, developing, manufacturing and delivering innovative
human therapeutics. This approach begins by using tools like
advanced human genetics to unravel the complexities of disease and
understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages
its expertise to strive for solutions that improve health outcomes
and dramatically improve people's lives. A biotechnology pioneer
since 1980, Amgen has grown to be one of the world's leading
independent biotechnology companies, has reached millions of
patients around the world and is developing a pipeline of medicines
with breakaway potential.
For more information, visit www.amgen.com and follow us on
www.twitter.com/amgen.
Forward-Looking Statements
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release contains forward-looking statements that are based on the
current expectations and beliefs of Amgen. All statements, other
than statements of historical fact, are statements that could be
deemed forward-looking statements, including estimates of revenues,
operating margins, capital expenditures, cash, other financial
metrics, expected legal, arbitration, political, regulatory or
clinical results or practices, customer and prescriber patterns or
practices, reimbursement activities and outcomes and other such
estimates and results. Forward-looking statements involve
significant risks and uncertainties, including those discussed
below and more fully described in the Securities and Exchange
Commission reports filed by Amgen, including our most recent annual
report on Form 10-K and any subsequent periodic reports on Form
10-Q and Form 8-K. Unless otherwise noted, Amgen is providing this
information as of the date of this news release and does not
undertake any obligation to update any forward-looking statements
contained in this document as a result of new information, future
events or otherwise.
No forward-looking statement can be guaranteed and actual
results may differ materially from those we project.
Discovery or identification of new product candidates or
development of new indications for existing products cannot be
guaranteed and movement from concept to product is uncertain;
consequently, there can be no guarantee that any particular product
candidate or development of a new indication for an existing
product will be successful and become a commercial product.
Further, preclinical results do not guarantee safe and effective
performance of product candidates in humans. The complexity of the
human body cannot be perfectly, or sometimes, even adequately
modeled by computer or cell culture systems or animal models. The
length of time that it takes for us to complete clinical trials and
obtain regulatory approval for product marketing has in the past
varied and we expect similar variability in the future. Even when
clinical trials are successful, regulatory authorities may question
the sufficiency for approval of the trial endpoints we have
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The scientific information discussed in this news release
related to our product candidates is preliminary and investigative.
Such product candidates are not approved by the U.S. Food and Drug
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CONTACT: Amgen, Thousand
Oaks
Trish Hawkins, 805-405-1699
(media)
Kristen Davis, 805-447-3008
(media)
Arvind Sood, 805-447-1060
(investors)
1 Official Journal of the International Society of
Nephrology. KDIGO Clinical Practice Guideline for the Diagnosis,
Evaluation, Prevention, and Treatment of Chronic Kidney
Disease–Mineral and Bone Disorder (CKD–MBD). Available at:
www.kdigo.org/clinical_practice_guidelines/pdf/CKD/KDIGO%20CKD-MBD%20GL%20KI%20Suppl%20113.pdf.
Accessed July 28, 2016.
2 Kalantar-Zadeh K, Kuwae N, Regidor DL, et al. Survival
predictability of time-varying indicators of bone disease in
maintenance hemodialysis patients. Kidney Int.
2006;70:771-780.
3 National Kidney Foundation. Global Facts: About Kidney
Disease. Available at:
https://www.kidney.org/kidneydisease/global-facts-about-kidney-disease.
Accessed July 28, 2016.
4 National Kidney Foundation. Fast Facts. Available at:
https://www.kidney.org/news/newsroom/factsheets/FastFacts. Accessed
July 28, 2016.
5 Data on File, Amgen; 2016.
6 National Institutes of Health. MedlinePlus:
Hyperparathyroidism. Available at:
www.nlm.nih.gov/medlineplus/ency/article/001215.htm. Accessed
July 28, 2016.
7 National Kidney Foundation. Parathyroid Hormone and
Secondary Hyperparathyroidism in Chronic Kidney Disease. Available
at:
https://www.kidney.org/sites/default/files/02-10-4899_GB_SHPT-PTH_v8.pdf.
Accessed July 28, 2016.
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