Prolia(R) (Denosumab) Granted Marketing Authorization in the European Union

Friday, May 28, 2010 Corporate News
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Given as an Injection Every Six Months, Prolia Reduced the Risk of Fractures in Treatment of Postmenopausal Osteoporosis in Women at Increased Risk of Fractures

i  Cummings SR, et al. Twice Yearly Denosumab, a Monoclonal Antibody to RANK-ligand, for Prevention of Fractures in Postmenopausal Women with Osteoporosis. N Engl J Med, 2009 Aug. 20; published online at www.nejm.org on Aug. 11, 2009.'

ii  Smith MR, et al. Denosumab for the Prevention of Bone Loss and Fractures in Men Receiving Androgen Deprivation Therapy in Non-Metastatic Prostate Cancer. N Engl J Med, 2009 Aug. 20; published online at www.nejm.org on Aug. 11, 2009.

iii  Epidemiology." International Osteoporosis Foundation. Accessed at http://www.iofbonehealth.org/health-professionals/about-osteoporosis/epidemiology.html  on 10 March 2009.

iv  Cooper C. The crippling consequences of fractures and their impact on quality of life. Am J Med. 1997;103(2A):12S-17S.

v  "Facts and statistics about osteoporosis and its impact." International Osteoporosis Foundation. Accessed at http://www.iofbonehealth.org/facts-and-statistics.html on 10 March 2009.

vi  Ferlay J, et al. Estimates of the cancer incidence and mortality in Europe in 2006. Annals of Oncology, 2007 Feb. 7.

vii  Shahinian VB, Kuo YF, Freeman JL, Goodwin JS. Risk of fracture after androgen deprivation for prostate cancer. N Engl J Med. 2005;352(2):154-64.



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