Human therapeutics company Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels:UCB) said on Thursday that the European Medicines Agency (EMA) has adopted a positive opinion recommending Marketing Authorisation for EVENITY (romosozumab) for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture and with no history of myocardial infarction or stroke.
Amgen and UCB are co-developing EVENITY for osteoporosis. 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 ageing population these numbers will rise.
The CHMP (Committee for Medicinal Products for Human Use) of the European Medicines Agency's (EMA) recommendation of EVENITY will be reviewed by the European Commission (EC) and the final decision is expected by year-end 2019.
According to the partners, EVENITY is a novel bone-builder with a dual effect that increases bone formation and reduces bone resorption (or bone loss). 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.
Under the partnership's development programme, approximately 14,000 patients were enrolled in 19 clinical studies. EVENITY has been studied for its potential to reduce the risk of fractures in an extensive global Phase 3 programme that included two large fracture trials comparing EVENITY to either placebo or active comparator in nearly 11,000 postmenopausal women with osteoporosis.
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