THOUSAND OAKS, Calif.,
Feb. 25, 2015 /PRNewswire/ -- Amgen
(NASDAQ: AMGN) today announced results from the head-to-head Phase
3 study comparing AMG 416 with cinacalcet for the treatment of
secondary hyperparathyroidism (SHPT) in patients with chronic
kidney disease (CKD) receiving hemodialysis. The study met the
primary endpoint of non-inferiority of AMG 416 compared to
cinacalcet, measured as the achievement of a greater than 30
percent reduction from baseline in mean pre-dialysis serum intact
parathyroid hormone (PTH) levels during the Efficacy Assessment
Phase (EAP), defined as the period between weeks 20 and 27.
Further, AMG 416 was statistically significantly superior to
cinacalcet in the secondary endpoints of the proportion of patients
achieving greater than 50 percent (52.4 percent versus 40.2
percent) and greater than 30 percent (68.2 percent versus 57.7
percent) PTH reduction from baseline during the EAP. There was no
difference between the treatment arms in the mean number of days of
vomiting or nausea per week in the first eight weeks, another
secondary endpoint.
"These findings, combined with results from two positive
placebo-controlled studies of more than 1,000 patients, add to the
growing body of evidence that reinforce the promise of AMG 416 for
hemodialysis patients with secondary hyperparathyroidism," said
Sean E. Harper, M.D., executive vice
president of Research and Development at Amgen. "The management of
this disease in patients with chronic kidney disease is a complex
process, and at Amgen, we are committed to building upon our
leadership in nephrology to provide patients with an innovative
therapy that can be administered intravenously along with
hemodialysis."
Treatment-emergent adverse events (TEAEs) were reported in 92.9
and 90.0 percent of patients who received AMG 416 and cinacalcet,
respectively. TEAEs that were reported in greater than 10 percent
of patients in either arm included (AMG 416 versus cinacalcet,
respectively): blood calcium decreased (68.9 and 59.8 percent),
nausea (18.3 and 22.6 percent), vomiting (13.3 and 13.8 percent)
and diarrhea (6.2 and 10.3 percent). TEAEs of hypocalcemia
(symptomatic) were reported in 5.0 percent of patients who received
AMG 416 versus 2.3 percent in the cinacalcet group.
Treatment-emergent events related to cardiac failure were reported
in 3.0 percent of patients who received AMG 416 versus 0.6 percent
in the cinacalcet group. Serious adverse events were reported in
25.1 and 27.3 percent of patients who received AMG 416 and
cinacalcet, respectively. Fatal adverse events were reported in 2.7
percent for the AMG 416 arm and 1.8 percent for the cinacalcet
arm.
Study Design
This was a randomized, active-controlled,
double-blind, double-dummy study (study number 20120360) over 26
weeks that compared the efficacy and safety of AMG 416 with
cinacalcet for the treatment of SHPT in 683 patients with CKD
receiving hemodialysis.
Patients randomized to treatment with AMG 416 received
intravenous (IV) doses of AMG 416 three times per week at the end
of each dialysis session and daily oral doses of placebo tablets.
Subjects randomized to treatment with cinacalcet received daily
oral doses of cinacalcet tablets and IV doses of placebo three
times per week at the end of each dialysis session. Patients also
received standard of care, which could include calcium supplements,
vitamin D sterols and phosphate binders, if prescribed by the
individual physician.
The primary endpoint was the proportion of patients with greater
than 30 percent reduction from baseline in PTH levels during weeks
20 and 27, with the objective of demonstrating non-inferiority of
AMG 416 to cinacalcet.
Key and other secondary endpoints included the achievement of a
greater than 50 percent reduction from baseline in mean
pre-dialysis serum intact PTH during the EAP, achievement of a
greater than 30 percent reduction from baseline in mean
pre-dialysis serum intact PTH during the EAP, and the mean number
of days of vomiting or nausea per week in the first eight weeks.
Nausea or vomiting were collected by the Nausea/Vomiting Symptom
Assessment (NVSA) patient assessment daily questionnaires.
About Secondary Hyperparathyroidism
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. The disorder
develops early as an adaptive response to declining kidney function
when the parathyroid glands (four small glands in the neck)
increase the production of PTH in an effort to maintain normal
levels of calcium and phosphorus. Ultimately, excess PTH production
proves inadequate for maintaining normal serum calcium and
phosphorus levels. When kidney disease progresses to the point
where dialysis is needed to sustain life, SHPT manifests as
abnormal PTH, calcium and phosphorus levels that, in turn, can lead
to significant clinical consequences.
About AMG 416
AMG 416 is a novel calcimimetic agent in
Phase 3 clinical development for the treatment of SHPT that is
administered intravenously in patients with CKD who are receiving
hemodialysis. AMG 416 binds to and activates the calcium-sensing
receptor on the parathyroid gland, thereby decreasing serum intact
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 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.
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CONTACT: Amgen, Thousand
Oaks
Kristen Davis, 805-447-3008
(media)
Arvind Sood, 805-447-1060
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