FDA approves Amgen's Prolia
THOUSAND OAKS, Calif. The Food and Drug Administration has approved a new drug from Amgen for osteoporosis, Amgen said Tuesday.
The FDA approved Prolia (denosumab) as a treatment for postmenopausal women with osteoporosis at high risk for bone fractures.
“Today’s FDA approval of Prolia is the culmination of a scientific journey that started more than 15 years ago with Amgen’s discovery of an essential pathway that regulates bone metabolism,” Amgen CEO Kevin Sharer said. “Prolia is the result of this discovery and offers an important new medicine for postmenopausal women with osteoporosis at high risk for fracture.”
The FDA’s approval was based on a three-year late-stage clinical study involving 7,808 women. According to results of the study, treatment with Prolia resulted in greater bone density, stronger bones and reduced risk of fractures.