European Commission Approves EVENITY (romosozumab) For The Treatment Of Severe Osteoporosis In Postmenopausal Women At High Risk Of Fracture
[caption id="attachment_9277" align="aligncenter" width="747"] Press Release[/caption]
First New Osteoporosis Medicine Approved in the European Union (EU) Since 2010Novel Bone-Builder With a Dual Effect That Increases Bone Formation and Reduces Bone Loss
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.2This 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.
- 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 Information?https://www.pi.amgen.com/~/media/amgen/repositorysites/pi-amgen-com/evenity/evenity_pi_hcp_english.ashx
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SOURCE?Amgen