Dec. 11, 2019: Amgen and UCB 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 can increase bone formation and to a slighter extent reduces bone resorption (or bone loss).
EVENITY is an important step 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.
The approval received in October 2019 follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP). The first launches of EVENITY in the European Economic Area (EEA) are planned for the first half of 2020.
EVENITY (romosozumab) is a bone-forming monoclonal antibody, designed to work by inhibiting the activity of sclerostin, which concurrently results in increased bone formation and to a lesser extent decreased bone resorption. https://www.amgen.com/media/news-releases/2019/12/european-commission-approves-evenity-romosozumab-for-the-treatment-of-severe-osteoporosis-in-postmenopausal-women-at-high-risk-of-fracture/
