FDA Advisory Committee Reviews Prolia™ (Denosumab)
On August 13, 2009, the U.S. Food and Drug Administration’s Advisory Committee on Reproductive Health Drugs (ACRHD) reviewed the potential use of Prolia™ (denosumab) for the prevention and treatment of postmenopausal osteoporosis and the prevention and treatment of bone loss in patients undergoing hormone ablation for either prostate cancer or breast cancer.
Prolia is fully human monoclonal antibody that targets the RANK ligand. The RANK ligand is an essential regulator of osteoclasts (cells that break down bone).
After reviewing safety and efficacy data from 30 clinical studies, the ACRHD recommended approval of Prolia for the treatment of postmenopausal osteoporosis and the treatment of bone loss in patients undergoing hormone ablation for prostate cancer.
The ACRHD recommended against approval of Prolia to treat or prevent bone loss in women with breast cancer undergoing hormone ablation until more data are available.
The Committee also recommended against approval of Prolia for the prevention of bone loss in low-risk patients in all three populations.
The FDA is not obligated to follow the recommendations of its advisory committees, but often does.
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