European Medicines Agency Accepts Filing For EVENITY™ (Romosozumab)
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The MAA for EVENITY is based on results from three pivotal Phase 3 studies: FRAME, including 7,180 postmenopausal women with osteoporosis; ARCH, including 4,093 postmenopausal women with osteoporosis at high risk for fracture; and BRIDGE, including 245 men with osteoporosis. The agency will evaluate the clinical benefit:risk profile of EVENITY in these three pivotal studies, including the potential to increase BMD and reduce the risk of fractures in women with osteoporosis, as well as the cardiovascular safety signal seen in the ARCH study.
"We are currently seeing 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.1 Without adequate management, some fragility fractures may lead to a loss of autonomy in patients' daily lives," said Dr.
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 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 11,000 postmenopausal women with osteoporosis.
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. The study evaluated the effectiveness of EVENITY treatment (210 mg), 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 at high risk for fracture based on previous fracture history. The study evaluated 12 months of EVENITY treatment (210 mg) followed by at least 12 months of alendronate treatment (70 mg), compared with alendronate treatment alone, to determine effectiveness in reducing the incidence of clinical fracture (non-vertebral fracture and clinical vertebral fracture) and new vertebral fracture.
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 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
Osteoporosis is a condition that weakens bone over time, making them thinner, more brittle and more likely to break.2 Patients who experience an osteoporotic fracture are twice as likely to suffer a future fracture, yet approximately 80 percent of patients are not treated for underlying osteoporosis after a fracture.3
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*The trademark EVENITY™ is provisionally approved for use by the
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- Nguyen TV, Center JR, Eisman JA (2004) Osteoporosis: underrated, underdiagnosed and undertreated. Med J Aust 180:S18.
International Osteoporosis Foundation . What Is Osteoporosis? 2015. Available at: http://www.iofbonehealth.org/what-is-osteoporosis. AccessedAugust 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 January 3, 2018.
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