THOUSAND OAKS,
Calif., June 23,
2017 /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 a pediatric formulation (granules in
capsule for opening) of Mimpara® (cinacalcet). Approval
was recommended for the treatment of secondary hyperparathyroidism
(HPT) in children aged three years and older with end‑stage renal
disease (ESRD) on maintenance dialysis therapy in whom secondary
HPT is not adequately controlled with standard of care
therapy.
"We are pleased by today's positive CHMP opinion, as
Mimpara could provide an important therapeutic option for pediatric
patients living with secondary hyperparathyroidism," said
Sean E. Harper, M.D., executive vice
president of Research and Development at Amgen.
The Marketing Authorization Application for Mimpara was
based on studies Amgen began in 2007 to assess the use of Mimpara
in pediatric secondary HPT patients, who have very few treatment
options.
The CHMP positive opinion will now be reviewed by
the European Commission, 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, will take corresponding
decisions on the basis of the decision of the European
Commission.
About Secondary Hyperparathyroidism
Secondary hyperparathyroidism (HPT) is a chronic and
serious condition which affects many of the approximately two
million people throughout the world who are receiving
dialysis.1,2 It
occurs in both adults and children. Approximately 88 percent of
chronic kidney disease (CKD) patients on hemodialysis will develop
secondary HPT.3
Secondary HPT 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 phosphate from the
bone.4,5
Secondary HPT is often initially silent and asymptomatic. As a
result, secondary HPT is frequently underdiagnosed and
undertreated.6
About
Mimpara® (cinacalcet)
Mimpara® (cinacalcet) was originally
approved in the EU in 2004 and is the first oral calcimimetic agent
approved by the European Medicines Agency for the
treatment of secondary HPT in patients with ESRD on maintenance
dialysis therapy. The therapy is also approved in the EU for the
reduction of hypercalcemia in adult patients with parathyroid
carcinoma and 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
Hypocalcaemia
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. Cases of QT prolongation and ventricular
arrhythmia have been reported in patients treated with
cinacalcet. 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 in
adults. Once the maintenance dose has been established, serum
calcium should be measured approximately monthly.
For pediatric patients, closely monitor serum calcium
levels and patient compliance during treatment with Mimpara. Do not
initiate cinacalcet or increase the dose if non-compliance is
suspected. Prior to initiating cinacalcet and during treatment,
consider the risks and benefits of treatment and the ability of the
patient to comply with the recommendations to monitor and manage
the risk of hypocalcaemia. Inform pediatric patients and/or their
caregivers about the symptoms of hypocalcaemia and about the
importance of adherence to instructions about serum calcium
monitoring, and posology and method of administration. Serum
calcium should be measured within 1 week after initiation or dose
adjustment of Mimpara and weekly once the maintenance dose has been
established in pediatric patients.
Seizures: Cases of seizures have been
reported in patients treated with Mimpara. The threshold for
seizures is lowered by significant reductions in serum calcium
levels. Therefore, serum calcium levels should be closely monitored
in patients receiving Mimpara, particularly in patients with a
history of a seizure disorder.
Hypotension and/or worsening heart
failure: 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.
Co-administration with other medicinal
products: Administer Mimpara with caution in patients
receiving any other medicinal products known to lower serum
calcium. Closely monitor serum calcium. Patients receiving Mimpara
should not be given etelcalcetide. Concurrent administration may
result in severe hypocalcaemia.
General: Adynamic bone disease may develop if
PTH levels are chronically suppressed below approximately 1.5 times
the upper limit of normal with the iPTH assay. If PTH levels
decrease below the recommended target range in patients treated
with Mimpara, the dose of Mimpara and/or vitamin D sterols should
be reduced or therapy discontinued.
Testosterone levels: Testosterone levels are
often below the normal range in patients with end‑stage renal
disease. The clinical significance of these reductions in serum
testosterone is unknown.
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.
Lactose: Patients with rare hereditary
problems of galactose intolerance, the Lapp lactase deficiency or
glucose‑galactose malabsorption should not take this
medicine.
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 Sensipar® (cinacalcet) in the
U.S.
Sensipar is the first oral calcimimetic agent approved by
the FDA for the treatment of secondary HPT in adult patients with
CKD on dialysis. Sensipar is not indicated for use in adult
patients with CKD who are not on dialysis because of an increased
risk of hypocalcemia. The therapy is also approved in the U.S. for
treatment of hypercalcemia in adult patients with parathyroid
carcinoma and hypercalcemia in adult patients with primary
hyperparathyrodisim (HPT) for whom parathyroidectomy would be
indicated on the basis of serum calcium levels, but who are unable
to undergo parathyroidectomy. Sensipar binds to the calcium-sensing
receptor, resulting in a drop in PTH levels by inhibiting PTH
synthesis and secretion. The reduction in PTH is associated with a
concomitant decrease in serum calcium levels. Sensipar is not
indicated for use in pediatric patients (patients less than 18
years of age).
Sensipar Important Safety Information in the
U.S.
Contraindication: Sensipar®
(cinacalcet) treatment initiation is contraindicated if serum
calcium is less than the lower limit of the normal range (8.4
mg/dL).
Hypocalcemia: Sensipar®
lowers serum calcium and can lead to hypocalcemia. Life threatening
events and fatal outcomes associated with hypocalcemia have been
reported in patients treated with Sensipar®, including
pediatric patients. The safety and effectiveness of
Sensipar® have not been established in pediatric
patients.
Decreases in serum calcium can prolong the QT interval,
potentially resulting in ventricular arrhythmia. Cases of QT
prolongation and ventricular arrhythmia have been reported in
patients treated with Sensipar®. Patients with
conditions that predispose to QT interval prolongation and
ventricular arrhythmia may be at increased risk for QT interval
prolongation and ventricular arrhythmias if they develop
hypocalcemia due to Sensipar®. Closely monitor corrected
serum calcium and QT interval in patients at risk receiving
Sensipar®.
Significant reductions in calcium may lower the threshold
for seizures. Monitor serum calcium levels in patients with seizure
disorders on Sensipar®.
Concurrent administration of Sensipar® with
calcium-lowering drugs including other calcimimetics could result
in severe hypocalcemia. Parsabiv™ (etelcalcetide) and
Sensipar® should not be given together. Closely monitor
serum calcium in patients receiving Sensipar® and
concomitant therapies known to lower serum calcium
levels.
Patients with secondary HPT: Serum calcium and serum
phosphorus should be measured within 1 week and PTH should be
measured 1 to 4 weeks after initiation or dose adjustment of
Sensipar®. Once the maintenance dose has been established, serum
calcium and serum phosphorus should be measured approximately
monthly, and PTH every 1 to 3 months.
Patients with primary HPT or parathyroid carcinoma: Serum
calcium should be measured within 1 week after initiation or dose
adjustment of Sensipar®. Once maintenance dose levels
have been established, serum calcium should be measured every 2
months.
Upper Gastrointestinal Bleeding: Cases
of gastrointestinal (GI) bleeding, mostly upper GI bleeding, have
occurred in patients using calcimimetics, including
Sensipar®, from postmarketing and clinical trial
sources. The exact cause of GI bleeding in these patients is
unknown.
Patients with risk factors for upper GI bleeding, such as
known gastritis, esophagitis, ulcers or severe vomiting, may be at
increased risk for GI bleeding with Sensipar®. Monitor
patients for worsening of common Sensipar® GI adverse
reactions and for signs and symptoms of GI bleeding and ulcerations
during Sensipar® therapy.
Hypotension, Worsening Heart Failure and/or
Arrhythmias: In Sensipar® postmarketing
use, isolated, idiosyncratic cases of hypotension, worsening heart
failure, and/or arrhythmia were reported in patients with impaired
cardiac function. The causal relationship to Sensipar®
therapy could not be completely excluded and may be mediated by
reductions in serum calcium levels.
Adynamic Bone: Adynamic bone disease
may develop if intact parathyroid hormone (iPTH) levels are
suppressed below 100 pg/mL.
Adverse Reactions: In clinical trials
of patients with secondary HPT comparing Sensipar® to
placebo, the most commonly reported side effects were nausea (31
percent vs. 19 percent), vomiting (27 percent vs. 15 percent), and
diarrhea (21 percent vs. 20 percent). In clinical trials of
patients with primary HPT and parathyroid carcinoma treated with
Sensipar®, the most commonly reported side effects were nausea (63
percent), vomiting (46 percent), and paresthesia (20
percent).
Please see
Sensipar® Full
Prescribing Information.
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 Kidney
Disease: Improving Global Outcomes (KDIGO) CKD-MBD Work Group.
KDIGO clinical practice guideline for the diagnosis, evaluation,
prevention, and treatment of chronic kidney disease-mineral and
bone disorder (CKD-MBD). Kidney Int Suppl. 2009; 76(Suppl
113).
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 Data on
File, Amgen; 2016.
4 National
Institutes of Health. MedlinePlus: Hyperparathyroidism. Available
at: www.nlm.nih.gov/medlineplus/ency/article/001215.htm. Accessed
April 28, 2017.
5 Moe SM.
Disorders involving calcium, phosphorus, and magnesium. Prim
Care Clin Office Pract. 2008;35:215-237.
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 June 14, 2017.
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SOURCE Amgen