European Commission Authorizes Evenity for Severe Osteoporosis
The European Commission granted market authorization to Amgen’s Evenity (romosozumab) for 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 reduces bone loss.
The approval follows an October 2019 positive opinion from the EMA’s Committee for Medicinal Products for Human Use.
The drug is now approved in 37 countries, including the U.S., Japan, Canada, and Australia.