FDA committee recommends approval of Amgen’s Prolia

THOUSAND OAKS, Calif. A committee of scientists from the Food and Drug Administration has recommended approval of a new drug for treating bone loss.

Biotech company Amgen announced last week that the FDA’s Advisory Committee for Reproductive Health Drugs said Prolia (denosumab) should be approved as a treatment for postmenopausal osteoporosis and for treating bone loss in patients undergoing hormone ablation for prostate cancer following a review of safety and efficacy data from 30 clinical studies involving more than 12,000 patients.

At the same time, the committee declined to recommend approval for Prolia as a treatment for bone loss in women undergoing hormone ablation for breast cancer until additional data become available or for treating bone loss for low-risk patients in all three groups.

FDA advisory committees’ recommendations do not guarantee approval for a drug, but are taken into account when the agency makes its final decision.