European Commission approves Evenity for severe osteoporosis.- Amgen + UCB

Amgen and UCB announced that the European Commission 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). 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.

Comment: 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.