EC to review a recommendation for approving Amgen, UCB’s Evenity for certain osteoporosis

Amgen and UCB said Friday that Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has re-examined and recommended Marketing Authorization 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.

Evenity increases bone formation and to a lesser extent reduces bone resorption (or bone loss).

David M. Reese, executive vice president of Research and Development at Amgen said that Evenity is an important therapeutic development for osteoporosis. He said that the European Commission’s decision later this year is expected to be affirmative.

The European Commission will now review the CHMP’s recommendation, and should have decision by year-end 2019.

Evenity is approved in U.S. for the treatment of osteoporosis in postmenopausal women at high risk for fracture, in Japan and South Korea for the treatment of osteoporosis for women and men at high risk for fracture, in Canada for the treatment of osteoporosis for postmenopausal women at high risk for fracture, and in Australia for the treatment of osteoporosis in postmenopausal women at high risk of fracture and as a treatment to increase bone mass in men with osteoporosis at high risk of fracture.