Denosumab (formerly known as AMG 162, proposed trade name Prolia is a fully-human monoclonal antibody which is being studied in the treatment of osteoporosis, treatment-induced bone loss, bone metastases, rheumatoid arthritis, multiple myeloma and giant cell tumor of bone.
Denosumab is designed to target RANKL (RANK ligand), a protein that acts as the primary signal to promote bone removal. In many bone loss conditions, RANKL overwhelms the body'...
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Denosumab (formerly known as AMG 162, proposed trade name Prolia is a fully-human monoclonal antibody which is being studied in the treatment of osteoporosis, treatment-induced bone loss, bone metastases, rheumatoid arthritis, multiple myeloma and giant cell tumor of bone.
Denosumab is designed to target RANKL (RANK ligand), a protein that acts as the primary signal to promote bone removal. In many bone loss conditions, RANKL overwhelms the body's natural defense against bone destruction. Denosumab therefore mimicks the endogenous effects of osteoprotegerin.
Amgen has reported on two clinical trials designed and funded by the company:
The antibody is being developed by the company Amgen. The U.S. Food and Drug Administration (FDA) delayed approval of denosumab in October 2009 because the FDA need more information.
On August 13, 2009, the company issued a press release regarding the meeting that day with the Advisory Committee for Reproductive Health Drugs (ACRHD) of the U.S. Food and...
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