THOUSAND OAKS, Calif. and
BRUSSELS, Dec. 11, 2019 /PRNewswire/ -- Amgen
(NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) today announced that
the European Commission (EC) has granted marketing authorization
for EVENITY® (romosozumab) for the treatment of severe
osteoporosis in postmenopausal women at high risk of fracture.
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 her first fracture, a woman is five times more likely to
suffer another fracture within a year.1 EVENITY is a
significant step forward in the management of osteoporosis for
physicians who need to treat patients with a medicine that can
rapidly increase bone mineral density within 12 months," said
David M. Reese, M.D., executive vice
president of Research and Development at Amgen. "We are pleased by
the European Commission's approval to make this therapy available
to the millions of women at high risk of fracture in the European
Union."
The approval follows a positive opinion from the Committee for
Medicinal Products for Human Use (CHMP) that was received in
October 2019. The first launches of
EVENITY in the European Economic Area (EEA) are planned for first
half of 2020.
As the population ages, the incidence and contribution of
fragility fractures to the overall healthcare spend in Europe will continue to rise. Recent studies
estimate that every year €37 billion is spent on healthcare costs
for the 2.7 million fragility fractures that occur across
France, Germany, Italy, Spain,
Sweden and the UK.2
This annual expenditure is predicted to increase to over €47
billion by 2030.2
"Today's European population is living longer and expecting more
out of life in their later years. Yet fragility fractures due to
osteoporosis affect one in three women aged over 50, and evidence
shows that many women remain undiagnosed and untreated following a
fracture. These fractures represent a barrier to healthy aging,
potentially impacting independence and quality of
life2," said Dr. Pascale Richetta, head of bone and
executive vice president, UCB. "With today's approval of EVENITY we
can now offer patients and clinicians a new medicine that can help
drive positive changes in secondary fracture prevention."
"Fragility fractures can often be avoided, but their
prevention and management are being neglected despite a large
personal, societal and economic impact. With the number of
worldwide fractures expected to rise there is a growing need to
take action and prioritize post-fracture care through better
education, specialist services, lifestyles and medicines," said
Alison Doyle, head of clinical
operations for the Royal Osteoporosis Society. "Therefore, we
welcome this approval as it represents a new, therapeutic option
for both patients and health care professionals in addressing
this neglected condition."
European Commission marketing authorization approval is valid in
all EU and EEA-European Free Trade Association (EFTA)
states
(Norway, Iceland and Liechtenstein). EVENITY is
now approved in 37 countries, including the U.S., Japan, Canada
and Australia.
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 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.3 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.4 Without proper care or access to effective
intervention options, they remain at risk of painful and disabling
fractures in the future.
Important EU/EEA Product Information
EVENITY® (romosozumab) is indicated for treatment of
severe osteoporosis in postmenopausal women at high risk of
fracture.
Important EU/EEA Safety information
This medicinal product is subject to additional
monitoring. This will allow quick identification of new
safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
Contraindications
EVENITY is contraindicated in patients with a history of
myocardial infraction or stroke. EVENITY is contraindicated in
patients with hypocalcemia. EVENITY is contraindicated in patients
with a history of systemic hypersensitivity to romosozumab or to
any component of the product formulation.
Special Warning and Precautions for Use
Myocardial infarction and stroke: In randomised controlled
studies, an increase in serious cardiovascular events (myocardial
infarction and stroke) has been observed in romosozumab treated
patients compared to controls. Romosozumab is contraindicated in
patients with previous myocardial infarction or stroke.
When determining whether to use romosozumab for an individual
patient, consideration should be given to her fracture risk over
the next year and her cardiovascular risk based on risk
factors (e.g. established cardiovascular disease, hypertension,
hyperlipidaemia, diabetes mellitus, smoking, severe renal
impairment, age). Romosozumab should only be used if the prescriber
and patient agree that the benefit outweighs the risk. If a patient
experiences a myocardial infarction or stroke during therapy,
treatment with romosozumab should be discontinued.
Hypocalcemia: Transient hypocalcemia has been
observed in patients receiving romosozumab. Hypocalcemia should be
corrected prior to initiating therapy with romosozumab and patients
should be monitored for signs and symptoms of hypocalcemia. If any
patient presents with suspected symptoms of hypocalaemia during
treatment, calcium levels should be measured. Patients should be
adequately supplemented with calcium and vitamin D. Patients with
severe renal impairment (estimated glomerular filtration rate
[eGFR] 15 to 29 ml/min/1.73 m2) or receiving dialysis are at
greater risk of developing hypocalcemia and the safety data for
these patients is limited. Calcium levels should be monitored in
these patients.
Hypersensitivity: Clinically significant hypersensitivity
reactions, including angioedema, erythema multiforme, and urticaria
occurred in the romosozumab group in clinical trials. If an
anaphylactic or other clinically significant allergic reaction
occurs, appropriate therapy should be initiated and use of
romosozumab should be discontinued.
Osteonecrosis of the Jaw (ONJ): ONJ, has been
reported rarely in patients receiving romosozumab. The following
risk factors should be considered when evaluating a patient's risk
of developing ONJ:
- potency of the medicinal product that inhibits bone resorption
(the risk increases with the antiresorptive potency of the
compound), and cumulative dose of bone resorption therapy.
- cancer, co-morbid conditions (e.g. anaemia, coagulopathies,
infection), smoking.
- concomitant therapies: corticosteroids, chemotherapy,
angiogenesis inhibitors, radiotherapy to head and neck.
- poor oral hygiene, periodontal disease, poorly fitting
dentures, history of dental disease, invasive dental procedures
e.g. tooth extractions.
All patients should be encouraged to maintain good oral hygiene,
receive routine dental check-ups, and immediately report any oral
symptoms such as dental mobility, pain or swelling or non-healing
of sores or discharge during treatment with romosozumab.
Patients who are suspected of having or who develop ONJ while on
romosozumab should receive care by a dentist or an oral surgeon
with expertise in ONJ. Discontinuation of romosozumab therapy
should be considered until the condition resolves and contributing
risk factors are mitigated where possible.
Atypical Femoral Fractures: Atypical low-energy or
low trauma fracture of the femoral shaft, which can occur
spontaneously, has been reported rarely in patients receiving
romosozumab. Any patient who presents with new or unusual thigh,
hip, or groin pain should be suspected of having an atypical
fracture and should be evaluated to rule out an incomplete femur
fracture. Patient presenting with an atypical femur fracture should
also be assessed for symptoms and signs of fracture in the
contralateral limb. Interruption of romosozumab therapy should be
considered, based on an individual benefit-risk assessment.
Adverse Reactions: The most common adverse reactions
were nasopharyngitis (13.6%) and arthralgia (12.4%). Common adverse
reactions included hypersensitivity, sinusitis, rash, dermatitis,
headache, neck pain, muscle spasms and injection site reactions
(most frequent injection site reactions were pain and erythema).
Uncommon adverse reactions were urticaria, hypocalcaemia, stroke,
myocardial infarction and cataract. Finally, rare side effects were
serious allergic reactions which caused swelling of the face,
throat, hands, feet, ankles or lower legs (angioedema) and acute
skin eruption (erythema multiforme).
Refer to the European Summary of Product Characteristics for
other adverse reactions and full prescribing information for
EVENITY®.
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.5
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
EVENITY® 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 EVENITY®-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 U.S.
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 7 500 people in approximately 40 countries, the company
generated revenue of € 4.6 billion in 2018. UCB is listed on
Euronext Brussels (symbol: UCB). Follow us on Twitter:
@UCB_news.
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Arvind Sood, 805-447-1060
(investors)
CONTACT: UCB, Brussels
Scott Fleming, Bone Communications,
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Laurent Schots, Media Relations,
UCB, T+32.2.559.92.64, laurent.schots@ucb.com
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Isabelle Ghellynck, Investor Relations, UCB, T+32.2.559.9588,
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References
- Lindsay R, Silverman SL, Cooper C, et al. Risk of new vertebral
fracture in the year following fracture. JAMA.
2001;285(3):320-323.
- International Osteoporosis Foundation. Broken Bones, Broken
Lives: A Roadmap to Solve the Fragility Fracture Crisis in
Europe.
http://share.iofbonehealth.org/EU-6-Material/Reports/IOF%20Report_EU.pdf
Accessed November 18, 2019.
- International Osteoporosis Foundation. Patient Brochure.
http://share.iofbonehealth.org/WOD/2012/patient_brochure/WOD12-pa-tient_brochure.pdf.
Accessed November 18, 2019.
- Nguyen TV, Center JR, Eisman JA (2004) Osteoporosis:
underrated, underdiagnosed and undertreated. Med J Aust
180:S18.
- EVENITY™ (romosozumab-aqqg) U.S. Prescribing
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