THOUSAND OAKS, Calif. and
BRUSSELS, Oct. 17, 2019 /PRNewswire/ -- Amgen
(NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) today announced that
following a re-examination procedure, the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency
(EMA) has adopted a positive opinion recommending Marketing
Authorization for EVENITY® (romosozumab) for the
treatment of severe osteoporosis in postmenopausal women at high
risk of fracture and with no history of myocardial infarction or
stroke. EVENITY is a novel bone-builder with a dual effect that
increases bone formation and to a lesser extent reduces bone
resorption (or bone loss).
"After a fracture, postmenopausal women with osteoporosis are
five times more likely to fracture in the subsequent
year,1 and these fractures can be life-changing," said
David M. Reese, M.D., executive vice
president of Research and Development at Amgen. "We are pleased by
the Committee's opinion because we believe EVENITY is an important
therapeutic development for osteoporosis, and we look forward to
the European Commission's decision later this year."
The CHMP's recommendation will now be reviewed by the European
Commission (EC), which has the authority to approve medicines for
use throughout the European Union. A European Commission decision
is expected by year-end 2019.
"Post-menopausal osteoporosis and fragility fractures are
significant women's health issues that are far too often
overlooked, with evidence suggesting that an estimated 77 percent
of women aged 67 or older remain undiagnosed and untreated in the
first 6 months after a fracture.2 This is why new
treatment options are so important," said Dr. Pascale Richetta, head of bone and executive
vice president, UCB. "We believe that the Committee's positive
opinion is an important step forward to help improve the lives of
postmenopausal women with severe osteoporosis who are at high risk
of fragility fractures."
EVENITY is approved in U.S. for the treatment of osteoporosis in
postmenopausal women at high risk for fracture.3 EVENITY
is also approved in Japan and
South Korea for the treatment of
osteoporosis for women and men at high risk for fracture, in
Canada for the treatment of
osteoporosis for postmenopausal women at high risk for fracture,
and in Australia for the treatment
of osteoporosis in postmenopausal women at high risk of fracture
and as a treatment to increase bone mass in men with osteoporosis
at high risk of fracture. 4-7
About
EVENITY® (romosozumab)
EVENITY is a bone-forming monoclonal antibody. It is designed to
work by inhibiting the activity of sclerostin, which simultaneously
results in increased bone formation and to a lesser extent
decreased bone resorption. The EVENITY development program includes
19 clinical studies that enrolled approximately 14,000 patients.
EVENITY has been studied for its potential to reduce the risk of
fractures in an extensive global Phase 3 program that included two
large fracture trials comparing EVENITY to either placebo or active
comparator in nearly 11,000 postmenopausal women with
osteoporosis. Amgen and UCB are co-developing
EVENITY.
About the Pivotal EVENITY Clinical Trials
FRAME
(Fracture study in postmenopausal women with osteoporosis) is a
randomized, double-blind, placebo-controlled study that evaluated
7,180 postmenopausal women with osteoporosis at risk for fracture.
The study evaluated the effectiveness of EVENITY treatment (210 mg,
administered monthly), compared with placebo, in reducing the risk
of new vertebral fractures through 12 months. The study also
evaluated the effectiveness of treating with EVENITY for 12 months
followed by denosumab for 12 months, compared with placebo followed
by denosumab, in reducing the risk of new vertebral fractures
through 24 months.
ARCH (Active-controlled fracture study in postmenopausal women
with osteoporosis at high risk of fracture) is a randomized,
double-blind, alendronate-controlled study of EVENITY in 4,093
postmenopausal women with osteoporosis and previous fracture
history. This event-driven study evaluated 12 months of EVENITY
treatment (210 mg, administered monthly), followed by at least 12
months of alendronate treatment (70 mg), compared with alendronate
treatment alone, to assess its efficacy in reducing the risk of
clinical fracture (non-vertebral fracture and symptomatic vertebral
fracture) through the primary analysis period and the incidence of
new vertebral fracture at 24 months.
BRIDGE (Placebo-controlled study evaluating the efficacy
and safety of romosozumab in treating men with osteoporosis)
is a randomized, double-blind, placebo-controlled study of 245 men
aged 55-90 years with osteoporosis and a history of fragility
fracture (excluding hip fracture) or vertebral fracture. The study
evaluated the effectiveness of EVENITY treatment (210 mg,
administered monthly) for 12 months, compared with placebo, in
increasing bone mineral density (BMD) at the lumbar spine and the
effect on BMD at the femoral neck and total hip.
About Osteoporosis-Related Fractures
Worldwide, one in
three women and one in five men, over the age of 50, will suffer a
fragility fracture due to osteoporosis and with an aging population
these numbers will rise.8 Yet despite this, there
is a large gap in the management and treatment of osteoporosis,
especially in the post-fracture setting, with an estimated four out
of five patients remaining undiagnosed and untreated after a
fracture.9 Without proper care or access to effective
intervention options, they remain at risk of painful and disabling
fractures in the future.
Important U.S. Product Information
EVENITY®
is indicated for the treatment of osteoporosis in postmenopausal
women at high risk for fracture, defined as a history of
osteoporotic fracture, or multiple risk factors for fracture; or
patients who have failed or are intolerant to other available
osteoporosis therapy.
The anabolic effect of EVENITY wanes after 12 monthly doses of
therapy. Therefore, the duration of EVENITY use should be limited
to 12 monthly doses. If osteoporosis therapy remains warranted,
continued therapy with an anti-resorptive agent should be
considered.
Important U.S. Safety Information
POTENTIAL RISK OF MYOCARDIAL INFARCTION, STROKE AND
CARDIOVASCULAR DEATH
EVENITY® may increase the risk of myocardial
infarction, stroke and cardiovascular death. EVENITY®
should not be initiated in patients who have had a myocardial
infarction or stroke within the preceding year. Consider whether
the benefits outweigh the risks in patients with other
cardiovascular risk factors. Monitor for signs and symptoms of
myocardial infarction and stroke and instruct patients to seek
prompt medical attention if symptoms occur. If a patient
experiences a myocardial infarction or stroke during therapy,
EVENITY® should be discontinued.
In a randomized controlled trial in postmenopausal women, there
was a higher rate of major adverse cardiac events (MACE), a
composite endpoint of cardiovascular death, nonfatal myocardial
infarction and nonfatal stroke, in patients treated with
EVENITYTM compared to those treated with
alendronate.
Contraindications: EVENITY® is contraindicated
in patients with hypocalcemia. Pre-existing hypocalcemia must be
corrected prior to initiating therapy with EVENITY®.
EVENITY® is contraindicated in patients with a history
of systemic hypersensitivity to romosozumab or to any component of
the product formulation. Reactions have included angioedema,
erythema multiforme and urticaria.
Hypersensitivity: Hypersensitivity reactions, including
angioedema, erythema multiforme, dermatitis, rash and urticaria
have occurred in EVENITYTM-treated patients. If an
anaphylactic or other clinically significant allergic reaction
occurs, initiate appropriate therapy and discontinue further use of
EVENITY®.
Hypocalcemia: Hypocalcemia has occurred in patients
receiving EVENITY®. Correct hypocalcemia prior to
initiating EVENITY®. Monitor patients for signs and
symptoms of hypocalcemia, particularly in patients with severe
renal impairment or receiving dialysis. Adequately supplement
patients with calcium and vitamin D while on
EVENITY®.
Osteonecrosis of the Jaw (ONJ): ONJ, which can occur
spontaneously, is generally associated with tooth extraction and/or
local infection with delayed healing, and has been reported in
patients receiving EVENITY®. A routine oral exam should
be performed by the prescriber prior to initiation of
EVENITY®. Concomitant administration of drugs associated
with ONJ (chemotherapy, bisphosphonates, denosumab, angiogenesis
inhibitors, and corticosteroids) may increase the risk of
developing ONJ. Other risk factors for ONJ include cancer,
radiotherapy, poor oral hygiene, pre-existing dental disease or
infection, anemia and coagulopathy.
For patients requiring invasive dental procedures, clinical
judgment should guide the management plan of each patient. Patients
who are suspected of having or who develop ONJ should receive care
by a dentist or an oral surgeon. In these patients, dental surgery
to treat ONJ may exacerbate the condition. Discontinuation of
EVENITY® should be considered based on benefit-risk
assessment.
Atypical Femoral Fractures: Atypical low-energy or low
trauma fractures of the femoral shaft have been reported in
patients receiving EVENITY®. Causality has not been
established as these fractures also occur in osteoporotic patients
who have not been treated.
During EVENITY® treatment, patients should be advised
to report new or unusual thigh, hip or groin pain. Any patient who
presents with thigh or groin pain should be evaluated to rule out
an incomplete femur fracture. Interruption of EVENITY®
therapy should be considered based on benefit-risk assessment.
Adverse Reactions: The most common adverse reactions
(≥ 5%) reported with EVENITY® were arthralgia and
headache.
EVENITY® is a humanized monoclonal antibody. As with
all therapeutic proteins, there is potential for
immunogenicity.
Please see accompanying EVENITY® full
Prescribing Information, including Boxed Warning and
Medication Guide.
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 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 the world's
largest independent biotechnology company, 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 7,700 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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https://www.ebs.tga.gov.au/servlet/xmlmillr6?dbid=ebs/PublicHTML/pdfStore.nsf&docid=D3CCEA90E71D6635CA25842A00421D00&agid=(PrintDetailsPublic)&actionid=1
(August 2019)
- International Osteoporosis Foundation. Patient Brochure.
http://share.iofbonehealth.org/WOD/2012/patient_brochure/WOD12-pa-tient_brochure.pdf.
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SOURCE Amgen