THOUSAND OAKS, Calif. and
BRUSSELS, Sept. 11, 2017 /PRNewswire/ -- Amgen
(NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) today announced
detailed results from the Phase 3 ARCH study showing that 12 months
of EVENITY™* (romosozumab) followed by alendronate was superior in
reducing new vertebral, clinical, non-vertebral and hip fracture
risk in postmenopausal women with osteoporosis at high risk for
fracture, compared to alendronate alone. Overall adverse events and
serious adverse events were generally similar between the treatment
groups with the exception of the previously reported imbalance in
positively adjudicated cardiovascular serious adverse events. The
results were simultaneously published in the New England Journal
of Medicine (NEJM) and presented today as a late-breaking
abstract at an oral scientific session at the Annual Meeting of the
American Society for Bone Mineral Research (ASBMR) in
Denver.
The study found that through 24 months, postmenopausal
women with osteoporosis in the EVENITY treatment group experienced
a statistically significant 48.0 percent relative reduction in the
risk of a new vertebral (spine) fracture compared with those
receiving alendronate alone (6.2 percent versus 11.9 percent,
respectively [p<0.001]). At primary analysis, women in
the EVENITY treatment group also experienced a statistically
significant 27.0 percent relative reduction in the risk of clinical
fracture, which includes non-vertebral fracture and clinical
vertebral fracture (9.7 percent versus 13.0 percent, respectively
[p<0.001]).
"The ARCH study shows that romosozumab can provide
superior fracture risk reduction over alendronate, a commonly used,
first-line osteoporosis treatment," said study lead author
Kenneth F. Saag, M.D., M.Sc.,
professor of medicine at the University of
Alabama at Birmingham School of Medicine. "By sharing the
detailed results of efficacy and safety, we aim to help clinicians
understand the future benefit:risk profile of romosozumab and its
potential as a treatment option for postmenopausal women living
with osteoporosis."
At primary analysis, postmenopausal women in the EVENITY
treatment group experienced a statistically significant 19.0
percent relative reduction in the risk of non-vertebral fractures
(8.7 percent versus 10.6 percent, respectively
[p=0.04]). A 38.0 percent relative reduction in the risk of
hip fractures was also observed (2.0 percent versus 3.2 percent,
respectively [nominalp=0.015]), when compared to those
receiving alendronate alone.
Postmenopausal women who received EVENITY achieved greater
gains in bone mineral density (BMD) from baseline at all measured
sites and at all time points of the study versus those receiving
alendronate alone. At month 12, the percentage change from baseline
was greater with EVENITY versus alendronate at the lumbar spine
(13.7 percent versus 5.0 percent, respectively [p<0.001])
and total hip (6.2 percent versus 2.8 percent, respectively
[p<0.001]). In a subset of patients assessed
every six months, significant gains were observed beginning at
month six (p<0.001) for all sites.
Overall, adverse events and serious adverse events were
generally similar between the treatment groups. An imbalance in
adjudicated cardiovascular serious adverse events was observed
during the 12-month period in 50 patients (2.5 percent) treated
with EVENITY versus 38 patients (1.9 percent) treated with
alendronate, with cardiac ischemic events and cerebrovascular
events accounting for the imbalance.
The percentage of patients with adverse events and serious
adverse events throughout the study as well as in the initial
12-month EVENITY treatment period were balanced between the groups,
including incidences of osteoarthritis, hypersensitivity, cancer
and hypocalcemia. Injection site reactions, mostly mild in
severity, were reported in 4.4 percent of patients in the EVENITY
treatment group and 2.6 percent in the alendronate group during the
initial 12-month period.
During the open-label alendronate period, there were two
positively adjudicated events of osteonecrosis of the jaw, one in a
patient treated with EVENITY followed by alendronate and one
treated with alendronate alone. There were six patients with
positively adjudicated events of atypical femoral fracture during
the open-label alendronate period, two patients treated with
EVENITY followed by alendronate and four treated with alendronate
alone.
About the ARCH Study
ARCH
(Active-contRolled FraCture Study in
Postmenopausal Women with Osteoporosis at High Risk of
Fracture) is a Phase 3 multicenter, international, randomized,
double-blind, alendronate-controlled study of EVENITY in 4,093
postmenopausal women with osteoporosis at high risk for fracture
based on previous fracture history.
Patients were randomized 1:1 to receive either 210 mg
EVENITY subcutaneously every month or 70 mg alendronate orally
every week for the duration of the 12-month double-blind
alendronate-controlled study period. After the double-blind
active-comparator study period, patients received alendronate while
remaining blinded to their initial treatment assignment.
The incidence of new vertebral fracture was assessed at 24
months. The incidence of clinical fracture was assessed at the
primary analysis, when 330 clinical fractures occurred or the last
patient was on the study for 24 months, whichever was later. In
addition, other key fracture endpoints including non-vertebral
fracture and hip fracture were assessed at primary
analysis.
About EVENITY™* (romosozumab)
EVENITY is an investigational bone-forming monoclonal
antibody and is not approved by any regulatory authority for the
treatment of osteoporosis. It is designed to work by inhibiting the
activity of sclerostin, which enables EVENITY to rapidly increase
bone formation and reduce bone resorption simultaneously. EVENITY
is being studied for its potential to reduce the risk of fractures
in an extensive global Phase 3 program. This program includes two
large fracture trials comparing EVENITY to either placebo or active
comparator in more than 10,000 postmenopausal women with
osteoporosis. Amgen and UCB are co-developing EVENITY.
About Osteoporosis
Osteoporosis is
a condition that weakens bone over time, making them thinner, more
brittle and more likely to break.1 Patients who
experience an osteoporotic fracture are twice as likely to suffer a
future fracture, yet more than 80 percent of fractures are not
treated for underlying osteoporosis.2
About the Amgen and UCB
Collaboration
Since 2004, Amgen and UCB have
been working together under a collaboration and license agreement
to research, develop and market antibody products targeting the
protein sclerostin. As part of this agreement, the two companies
continue to collaborate on the development of romosozumab for the
treatment of osteoporosis. This gene-to-drug project demonstrates
how Amgen and UCB are joining forces to translate a genetic
discovery into a new medicine, turning conceptual science into a
reality.
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.
About UCB
UCB, Brussels, Belgium (www.ucb.com) is a global
biopharmaceutical company focused on the discovery and development
of innovative medicines and solutions to transform the lives of
people living with severe diseases of the immune system or of the
central nervous system. With more than 7,500 people in
approximately 40 countries, the company generated revenue of € 4.2
billion in 2016. UCB is listed on Euronext Brussels (symbol: UCB).
Follow us on Twitter: @UCB_news
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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)
CONTACT: UCB, Brussels
France Nivelle, Global Communications,
UCB
T +32.2.559.9178,
france.nivelle@ucb.com
Scott Fleming, Global
Communications Lead, Bone,
UCB
T+447702777378, scott.fleming@ucb.com
Laurent
Schots, Media Relations, UCB
T+32.2.559.92.64,
laurent.schots@ucb.com
Antje Witte, Investor Relations,
UCB
T +32.2.559.94.14,
antje.witte@ucb.com
Isabelle Ghellynck, Investor Relations,
UCB
T+32.2.559.9588, isabelle.ghellynck@ucb.com
*The trade name EVENITY™ is provisionally approved for use
by the U.S. Food and Drug Administration and the European Medicines
Agency.
- International Osteoporosis Foundation. What Is
Osteoporosis? 2015. Available at:
http://www.iofbonehealth.org/what-is-osteoporosis. Accessed
August 4, 2017.
- International Osteoporosis Foundation. Stop at One. One
Fracture Leads to
Another. http://share.iofbonehealth.org/WOD/2012/patient_brochure/WOD12-patient_brochure.pdf.
Accessed August 4, 2017.
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SOURCE Amgen