The EMA’s Committee for Medicinal Products for Human Use adopted a negative opinion for Evenity (romosozumab), the Amgen/UCB treatment for severe osteoporosis.
The FDA approved the drug in April for treatment of osteoporosis in postmenopausal women at high risk for fracture but required a boxed warning on the risk of heart attack, stroke and cardiovascular death.
UCB argues that the body of evidence supports a positive benefit-risk profile for the drug. “Together with Amgen we will seek a re-examination of the CHMP opinion,” said Pascale Richetta, a UCB executive vice president. The re-examination process “gives us the opportunity to clarify our position on the submitted data,” he said.