THOUSAND OAKS, Calif.,
Sept. 2, 2015 /PRNewswire/ -- Amgen
(NASDAQ: AMGN) today announced the submission of a Marketing
Authorization Application (MAA) to the European Medicines Agency
(EMA) via the centralized procedure for etelcalcetide (formerly AMG
416) for the treatment of secondary hyperparathyroidism (SHPT) in
adult patients with chronic kidney disease (CKD) on hemodialysis
therapy. If approved, etelcalcetide will be the first calcimimetic
agent that can be administered intravenously.
Etelcalcetide is a novel calcimimetic agent that suppresses the
secretion of parathyroid hormone and is in clinical development for
the treatment of SHPT in patients with CKD on hemodialysis.
Etelcalcetide is administered intravenously three times per week at
the end of each dialysis session. It acts by binding to and
activating the calcium-sensing receptor on the parathyroid gland,
thereby causing decreases in parathyroid hormone (PTH). Sustained
elevations in PTH are known to be associated with significant
clinical consequences for patients with CKD.
"Secondary hyperparathyroidism affects many of the approximately
two million people throughout the world on dialysis, yet there is
currently no calcimimetic that can be administered intravenously at
the end of scheduled dialysis sessions. Given that these patients
take an average of 19 pills daily, there is an opportunity to
improve their treatment as it relates to the administration of the
therapy," said Sean E. Harper, M.D.,
executive vice president of Research and Development at Amgen.
"Etelcalcetide has the potential to fill this unmet need, and we
look forward to working with regulatory authorities in hopes of
providing a new treatment option that could help improve the
complex management of the disease."
The MAA submission for etelcalcetide includes 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 etelcalcetide compared
with cinacalcet.
About Secondary Hyperparathyroidism (SHPT)
SHPT is a
common and serious condition that is often progressive among
patients with CKD, and it affects many of the approximately two
million people throughout the world who are receiving dialysis,
including approximately 350,000 people in Europe. The disorder develops early in the
course of CKD and usually manifests as increased levels of PTH as a
result of increased production from the parathyroid glands (four
small glands in the neck). Patients with end stage renal disease
who require maintenance dialysis often have substantial elevations
of PTH that are commonly associated with abnormal calcium and
phosphorus and an increased risk of significant clinical
consequences.
About Etelcalcetide
Etelcalcetide is a novel
calcimimetic agent in clinical development for the treatment of
SHPT in CKD patients on hemodialysis that is administered
intravenously at the end of the dialysis session. Etelcalcetide
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 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
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 biologics manufacturing 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
This news
release contains forward-looking statements that are based on
management's current expectations and beliefs and are subject to a
number of risks, uncertainties and assumptions that could cause
actual results to differ materially from those described. All
statements, other than statements of historical fact, are
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Please refer to Amgen's most recent Forms 10-K, 10-Q and 8-K for
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and expressly disclaims any duty to update information contained in
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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)
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