(Reuters) – An advisory panel to the U.S. Food and Drug Administration on Wednesday recommended Amgen Inc’s osteoporosis treatment for postmenopausal women at high risk for fracture, saying the benefits of the drug outweighed its risks.
The panel voted 15-1 in favor of the monthly injection, developed with Belgium-based UCB SA, that works as a bone forming agent. The drug, Evenity, helps reduce the risk of fracture by increasing bone formation and inhibiting break down of bone minerals.
Three other members of the panel voted in favor of the drug but proposed approving it for a different indication.
The FDA is not mandated to follow the recommendation of the panel, but generally does.
JANUARY 16, 2019