THOUSAND OAKS, Calif.,
Nov. 11, 2016 /PRNewswire/
-- Amgen (NASDAQ:AMGN) today announced that the European
Commission (EC) has granted marketing authorization for Parsabiv™
(etelcalcetide) for the treatment of secondary hyperparathyroidism
(sHPT) in adult patients with chronic kidney disease (CKD) on
hemodialysis. Parsabiv is the first calcimimetic agent that can be
administered intravenously by a healthcare provider three times a
week at the end of a hemodialysis session.
"Keeping relevant lab values in recommended target ranges
is an important part of managing sHPT, a chronic and complex
disease with an already complicated medication regimen for many
patients," said John Cunningham,
M.D., professor of nephrology at University College London Medical
School. "Treatment failures are quite common and Parsabiv provides
a new tool that should give physicians more confidence that
patients are getting the medication they need to treat their
sHPT."
The EC approved Parsabiv based on 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 with cinacalcet. Additionally, etelcalcetide was
superior to cinacalcet for the secondary endpoints of proportion of
patients achieving greater than 30 percent and greater
than 50 percent reduction in mean parathyroid hormone (PTH)
during the Efficacy Assessment Phase (EAP) compared with
baseline.
"Treatment adherence can be a challenge with any oral medicine,"
said Sean E. Harper, M.D., executive
vice president of Research and Development at Amgen. "If poorly
controlled, sHPT may progress and can have significant clinical
consequences. With Parsabiv, we can put the delivery of the therapy
in the hands of the healthcare provider and help ensure that these
patients receive this important treatment as part of their dialysis
session three times a week."
Approval from the EC grants a centralized marketing
authorization with unified labeling 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.1,2 In Europe, the
prevalence of sHPT within dialysis populations ranges from 30 to 49
percent.3 Approximately 88 percent of dialysis
patients and 79 percent of patients on hemodialysis will develop
sHPT.4 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.5 sHPT is often initially silent and
asymptomatic.1 As a result, sHPT is frequently
underdiagnosed and undertreated.1,6
About Parsabiv™ (etelcalcetide)
Parsabiv is a novel calcimimetic agent indicated for the
treatment of secondary hyperparathyroidism (sHPT) in adult patients
with chronic kidney disease (CKD) on hemodialysis therapy. 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.
Important Safety Information
Contraindications: Hypersensitivity to the active
substance or to any of the excipients. Parsabiv should not be
initiated if corrected serum calcium is less than the lower limit
of the normal range.
Special Warnings and Precautions:
Hypocalcaemia: Since etelcalcetide lowers serum calcium,
patients should be advised to seek medical attention if they
experience symptoms of hypocalcaemia and should be monitored for
the occurrence of hypocalcaemia. Serum calcium levels should
be measured prior to initiating treatment, within 1 week of
initiation or dose adjustment of Parsabiv and every 4 weeks during
treatment. Potential manifestations of hypocalcaemia include
paraesthesias, myalgias, muscle spasm and seizures. Decreases
in serum calcium can prolong the QT interval, potentially resulting
in ventricular arrhythmia. The threshold for seizures may be
lowered by significant reductions in serum calcium levels.
Worsening heart failure: Decreased myocardial performance,
hypotension, and congestive heart failure may be associated with
significant reductions in serum calcium levels.
Co-administration with other medicinal products
Administer Parsabiv with caution in patients receiving any other
medicinal products known to lower serum calcium. Patients receiving
Parsabiv should not be given cinacalcet. Concurrent administration
may result in severe hypocalcaemia.
Interactions: No interaction studies have been performed.
There is no known risk of pharmacokinetic interaction with
Parsabiv.
Fertility, Pregnancy and Lactation: There are no or
limited amount of data from the use of Parsabiv in pregnant women.
Animal studies do not indicate direct or indirect harmful effects
with respect to reproductive toxicity. As a precautionary
measure, it is preferable to avoid the use of Parsabiv during
pregnancy. A risk to breastfed newborns/infants cannot be
excluded. A decision must be made whether to discontinue
breast-feeding or discontinue/abstain from Parsabiv therapy taking
into account the benefit of breast-feeding for the child and the
benefit of therapy for the woman. No data are available on the
effect of etelcalcetide on human fertility. Animal studies do not
indicate direct or indirect harmful effects with respect to
fertility.
Undesirable Effects: The following common (≥10%) adverse
reactions have been reported in pivotal, controlled clinical
studies: decreases in serum calcium, diarrhoea, nausea, vomiting,
and muscle spasms.
Pharmaceutical Precautions: Store in a refrigerator (2
degrees C – 8 degrees C). Once removed from the
refrigerator, Parsabiv must be used within 7 days if stored in the
original carton.
About Mimpara® (cinacalcet)
Mimpara® (cinacalcet) is the first oral calcimimetic
agent approved by the European Medicines Agency 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
Contraindications: Hypersensitivity to the active
substance or to any of the excipients
Special Warnings and Precautions:
Serum Calcium:
Mimpara treatment should not be initiated in patients with a
serum calcium below the lower limit of the normal range. Life
threatening events and fatal outcomes associated with hypocalcaemia
have been reported in adult and paediatric patients treated with
Mimpara. Manifestations of hypocalcaemia may include paraesthesias,
myalgias, cramping, tetany and convulsions. Decreases in serum
calcium can also prolong the QT interval, potentially resulting in
ventricular arrhythmia secondary to hypocalcaemia. The threshold
for seizures is lowered by significant reductions in serum calcium
levels. Patients should be monitored carefully for the occurrence
of hypocalcaemia. Serum calcium should be measured within 1 week
after initiation or dose adjustment of Mimpara. Once the
maintenance dose has been established, serum calcium should be
measured approximately monthly.
Hypotension and/or worsening heart failure: In post-marketing
safety surveillance, isolated, idiosyncratic cases of hypotension
and/or worsening heart failure have been reported in patients with
impaired cardiac function, in which a causal relationship to
cinacalcet could not be completely excluded and may be mediated by
reductions in serum calcium levels.
Hepatic impairment:
Due to the potential for 2 to 4 fold higher plasma levels of
cinacalcet in patients with moderate to severe hepatic impairment,
Mimpara should be used with caution in these patients and treatment
should be closely monitored
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
http://www.ema.europa.eu
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.
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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 Tomasello S. Secondary Hyperparathyroidism and
Chronic Kidney Disease. Diabetes Spectrum. 2008
Jan;21(1)19-25.
2 Liyanage T, Ninomiya T, Jha V, et al. Worldwide
access to treatment for end-stage kidney disease: a systematic
review. Lancet. 2015; 385: 1975–82.
3 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
4 Data on File, Amgen; 2016.
5 National Institutes of Health. MedlinePlus:
Hyperparathyroidism. Available at:
www.nlm.nih.gov/medlineplus/ency/article/001215.htm.
Accessed November 8, 2016
6 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 November 8, 2016.
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