(Reuters) – An advisory panel to the U.S. Food and Drug Administration said on Wednesday that benefits of Amgen Inc’s osteoporosis treatment for postmenopausal women at high risk for fracture outweighed its risks and overwhelmingly voted for the drug’s approval.
The panel voted 16-1 in favor of the monthly injection developed jointly with Belgium-based UCB SA. The drug, Evenity, helps reduce the risk of fracture by increasing bone formation and inhibiting break down of bone minerals.
Three of the 19-member panel initially voted in favor of a different indication but one of them later said he meant to support the proposed use.
The panel, however, raised concerns of cardiovascular safety risks linked to the drug, which FDA staff reviewers on Monday had cited as the main reason for convening the panel meeting.
“I don’t think we’ve adequately characterized cardiovascular safety … I don’t know the perfect solution but relying on observational data only post approval, I don’t think, will help us answer this reliably,” said panel member Pamela Shaw, who voted in favor of the drug’s approval.
“My vote is relying on a high-quality post-marketing study.”