Denosumab pipeline update July 2008

[diana.papshev]

Denosumab by Amgen, FDA to complete review of postmenopausal osteoporosis (PMO) data by 2nd half of 2008 (in development for RA and multiple cancers)
• Class/MOA: fully-human monoclonal antibody that specifically targets RANK Ligand, the essential mediator of osteoclasts (the cells that break down bone)
• Use: treatment of postmenopausal osteoporosis (PMO) and treatment-induced bone loss
• Dosage form: SC injection
• Link to press release:

oAmgen Press Release 5/08
oAmgen Press Release 4/08

• Link to clinicaltrials.gov:

o Trials registered with NIH

• Link to published studies:

o Effects of Denosumab on Bone Mineral Density and Bone Turnover in Postmenopausal Women [Journal of Clinical Endocrinology & Metabolism. 2008]

UPDATE: The results of a Phase III study demonstrated BMD and vertebral fractures superiority compared to placebo in men with non-metastatic prostate cancer who are treated with androgen deprivation therapy:
News release 7/08