UCB and Amgen have announced that following a re-examination procedure, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended its osteoporosis drug, Evenity (romosozumab).
The committee adopted a positive opinion recommending Marketing Authorisation for the drug, specifically for the indication of severe osteoporosis in postmenopausal women at high risk of fracture and with no history of myocardial infarction or stroke.
Evenity, a novel bone-builder with a dual effect that increases bone formation and, to a lesser extent, reduces bone resorption, is already approved in US, for the treatment of osteoporosis in postmenopausal women at high risk for fracture.
The recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for use throughout the European Union. The companies have announced that a final decision is expected by year-end 2019.
After a fracture, postmenopausal women with osteoporosis are “five times more likely to fracture in the subsequent year, and these fractures can be life-changing,” said David M. Reese, MD, executive vice president of research and development at Amgen.
He continued, “We are pleased by the Committee’s opinion, which brings romosozumab one step closer to becoming a new osteoporosis treatment option for patients with severe osteoporosis at high risk of fracture in Europe.”
Postmenopausal women are susceptible to primary osteoporosis since osteoporosis is closely related to estrogen deficiency, which occurs during menopause.