Denosumab Receives Approval Recommendation for the Treatment of Post-Menopausal Osteoporosis

FDA Approval

On June 2, 2010, the Advisory Committee for Reproductive Health Drugs of the U.S. Food and Drug Administration recommended approval of denosumab, which will be marketed under the trade-name Prolia, for the treatment of post-menopausal osteoporosis.  The drug was also recommended for the treatment of bone loss in men receiving hormone suppressive therapy for prostate cancer.  The committee did not recommend the drug be approved for the treatment of osteopenia or to prevent bone loss in women receiving estrogen suppressive therapy for the treatment of breast cancer, citing a lack of data.

Denosumab is a selective biologic inhibitor of RANKL, a key step in the activation of osteoclasts, the cells responsible for remodeling bone.  The drug is a monoclonal antibody, administered twice-yearly as an injection.  Infections were increased among denosumab treated patients in the clinical trials of osteoporosis.

Denosumab has also been studied in RA, with demonstrated efficacy in suppressing the progression of articular erosions.  However, Denosumab demonstrated no effect on measures of disease activity (such as the number of swollen of tender joints).  The FDA committee did not recommend the drug for this indication.

Jon Giles, MD

About Jon Giles, MD