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Amgen Issues Statement on Outcomes of Advisory Committee for Reproductive Health Drugs (ACRHD) Meeting
Date:8/13/2009

cer based on these studies and a parallel trial in women with breast cancer. The FDA has provisionally approved the trade name Prolia in these proposed indications, for which denosumab is administered twice yearly subcutaneously at a 60mg dose. The Prolia trade name is only for these indications and may not apply for other indications of denosumab.

Amgen has also submitted marketing applications for use of Prolia in the European Union, Canada, Switzerland, and Australia.

About Osteoporosis

Often referred to as the "silent epidemic," osteoporosis is a global problem that is increasing in significance as the population of the world both increases and ages. In the U.S. today, nearly eight million women suffer from osteoporosis.(i) The World Health Organization (WHO) has recently identified osteoporosis as a priority health issue along with other major non-communicable diseases.

The economic burden of osteoporosis is comparable to that of other major chronic diseases; for example, in the U.S., the costs associated with osteoporosis-related fractures are equivalent to those of cardiovascular disease and asthma.(ii,iii,iv) It has been reported that osteoporosis results in more hospital bed-days than stroke, myocardial infarction or breast cancer.(v)

Bone Loss Due to Hormone Ablation

In the U.S., prostate cancer is the most common cancer in men and breast cancer is the most common cancer in women. It is common for prostate cancer and breast cancer patients to receive hormone ablation therapies that can lead to a decrease in bone mass and increased risk of fractures. Currently there are no approved therapies for bone loss in patients undergoing hormone ablation for either prostate or breast cancer.

About Amgen

Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen
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SOURCE Amgen Inc.
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