THOUSAND OAKS, Calif.,
Sept. 16, 2016 /PRNewswire/ -- Amgen
(NASDAQ:AMGN) today announced that the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency
(EMA) has adopted a positive opinion for the Marketing
Authorization of Parsabiv™ (etelcalcetide), recommending approval
for the treatment of secondary hyperparathyroidism (sHPT) in adult
patients with chronic kidney disease (CKD) on hemodialysis. If
approved, Parsabiv will be the first calcimimetic agent that can be
administered intravenously by a healthcare provider three times a
week at the end of a hemodialysis session.
"We are pleased to receive a positive CHMP opinion for Parsabiv,
which has demonstrated strong efficacy in clinical trials and could
help fill an unmet need in the delivery of this important therapy,"
said Sean E. Harper, M.D., executive
vice president of Research and Development at Amgen. "Secondary
hyperparathyroidism is a disease that affects many patients with
advanced chronic kidney disease, and we look forward to continuing
to work with regulatory authorities to provide these patients with
a novel therapy and advance the management of this complex
disease."
The Marketing Authorization Application (MAA) submission for
Parsabiv included data from three Phase 3 studies, all of which met
their primary endpoints, including two pooled placebo-controlled
trials in more than 1,000 patients and a head-to-head study
evaluating Parsabiv compared with cinacalcet.
The CHMP positive opinion will now be reviewed by the European
Commission (EC), which has the authority to approve medicines for
the European Union (EU). If approved, a centralized marketing
authorization with unified labeling will be granted in the 28
countries that are members of the EU. Norway, Iceland and Liechtenstein, as members of the European
Economic Area (EEA), will take corresponding decisions on the basis
of the decision of the EC.
About Secondary Hyperparathyroidism (sHPT)
sHPT is a
chronic and serious condition which affects many of the
approximately two million people throughout the world who are
receiving dialysis.1-4 In Europe, the prevalence of sHPT within dialysis
populations ranges from 30 to 49 percent.5 Approximately
88 percent of dialysis patients and 79 percent of patients on
hemodialysis will develop sHPT.6 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.7 sHPT is often initially silent and asymptomatic.
As a result, sHPT is frequently underdiagnosed and
undertreated.8
About Parsabiv™ (etelcalcetide)
Parsabiv is a novel
calcimimetic agent in clinical development for the treatment of
sHPT in adult CKD patients on hemodialysis that 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 Mimpara® (cinacalcet)
Mimpara® (cinacalcet) is the first oral calcimimetic
agent approved by the EMA for the treatment of sHPT in patients
with CKD on dialysis. The therapy is also approved in the EU for
the treatment of hypercalcemia in patients with parathyroid
carcinoma and hypercalcemia in adult patients with primary HPT for
whom parathyroidectomy would be indicated on the basis of serum
calcium levels (as defined by relevant treatment guidelines), but
in whom parathyroidectomy is not clinically appropriate or is
contraindicated. Mimpara binds to the calcium-sensing receptor,
resulting in a drop in PTH levels by inhibiting PTH synthesis and
secretion. In addition, the reductions in PTH lower serum calcium
and phosphorus levels.
Important Safety Information
Mimpara lowers serum
calcium; therefore, it is important that patients are carefully
monitored for the occurrence of hypocalcaemia. Mimpara should not
be initiated if serum calcium (corrected for albumin) is less than
the lower limit of the normal range. The threshold for seizures is
lowered by significant reductions in serum calcium levels. In the
treatment of secondary hyperparathyroidism the most commonly
reported adverse reactions in clinical trials were nausea and
vomiting.
To see the full Mimpara Safety Information, visit
www.ema.europa.eu/ema/
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
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than statements of historical fact, are statements that could be
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estimates and results. Forward-looking statements involve
significant risks and uncertainties, including those discussed
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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
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events or otherwise.
No forward-looking statement can be guaranteed and actual
results may differ materially from those we project.
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Further, preclinical results do not guarantee safe and effective
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human body cannot be perfectly, or sometimes, even adequately
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CONTACT: Amgen, Thousand
Oaks
Kristen Davis, 805-447-3008
(media)
Kristen Neese, 805-313-8267
(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 Hedgeman E, Lipworth L, Lowe K, et al. International
Burden of Chronic Kidney Disease and Secondary Hyperparathyroidism:
A Systematic Review of the Literature and Available Data. Int J
Neph. 2015;2015: 184321.
6 Data on File, Amgen; 2016.
7 National Institutes of Health. MedlinePlus:
Hyperparathyroidism. Available at:
www.nlm.nih.gov/medlineplus/ency/article/001215.htm. Accessed
July 28, 2016.
8 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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