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ARTICLE | Clinical News

Amgen, UCB report CV safety signal in Phase III of osteoporosis candidate Evenity

May 26, 2017 5:17 PM UTC

Amgen Inc. (NASDAQ:AMGN) and UCB S.A. (Euronext:UCB) no longer expect FDA to approve Evenity romosozumab (AMG 785, CDP7851) this year after data from the Phase III ARCH trial in 4,093 postmenopausal women with osteoporosis at high risk for fracture revealed a previously unseen cardiovascular (CV) safety signal. While Evenity met the co-primary endpoints of reducing the incidence of new vertebral fractures and clinical fractures at 24 months vs. alendronate (relative risk reductions of 50% and 27%, respectively), the companies said there was an imbalance in the incidence of positively adjudicated CV serious adverse events between treatment groups at 12 months (2.5% vs. 1.9%). A BLA for Evenity to treat osteoporosis in postmenopausal women at increased risk of fracture is under FDA review. Its PDUFA date is July 19.

In ARCH, Evenity also met the secondary endpoint by reducing the incidence of non-vertebral fractures vs. alendronate (relative risk reduction of 19%). Patients received once-monthly 210 mg subcutaneous Evenity for 12 months followed by alendronate for 12 months or alendronate for 24 months. Another secondary endpoint in the double-blind, international trial is the percent change from baseline in bone mineral density (BMD) as assessed by dual x-ray absorptiometry (DEXA)...

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