Advisory Committee to Review Denosumab Data
THOUSAND OAKS, Calif.,
"In the U.S., one woman in two over the age of 50 will experience an
osteoporotic fracture in her remaining lifetime. Although osteoporosis
treatments are available, there remains a need for other options that deliver
robust efficacy and support adherence to therapy," said
The FDA has provisionally approved the trade name Prolia(TM) for denosumab in the proposed indications of treatment and prevention of osteoporosis in postmenopausal women, and treatment and prevention of bone loss in patients undergoing hormone ablation for prostate or breast cancer.
Denosumab is the first fully human monoclonal antibody in late stage clinical development that specifically targets RANK Ligand, an essential regulator of osteoclasts (the cells that break down bone). Denosumab is being investigated for its potential to inhibit all stages of osteoclast activity through a targeted mechanism. Denosumab is being studied in a range of bone loss conditions including postmenopausal osteoporosis and bone loss in patients undergoing hormone ablation for prostate and breast cancer, as well as for its potential to delay bone metastases and inhibit and treat bone destruction across many stages of cancer.
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)
Hormone Ablation-Induced Bone Loss
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.
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The scientific information discussed in this news release related to our
product candidates is preliminary and investigative. Such product candidates
are not approved by the
Arvind Sood: (805) 447-1060 (investors)
(i) http://www.nof.org/osteoporosis/diseasefacts.htm, accessed, 3/18/2009: Main bullet #5
(ii) Burge R, et al. J Bone Miner Res. 2007; 22:465-475
(iii) "Osteoporosis Fast Facts."
(iv) "Economic Cost of Cardiovascular Diseases."
(v) Lippuner K, et al. "Incidence and direct medical costs of hospitalisations due to osteoporotic fractures in switzerland."