Two new studies suggest that the risk of bone fractures can now be reduced more than the prevalent medicines with a new osteoporosis drug, called denosumab. This genetically engineered drug was tested in older women and men being treated for prostate cancer and it was found that the rate of fractures was brought down by two- thirds. Made by the biotech company Amgen, it is now being reviewed by Food and Drug Administration(FDA) advisers for approval of the drug.
Denosumab, is the first to prevent the production of cells, called osteoclasts, that break down bones. The high efficiency rate, apparent lack of side effects and ease of administration are the main reasons why physicians have high hopes with this new drug. The only concern lies in the fact that it is likely to be the highest-priced osteoporosis drug among others in the market since it is not a chemical but a hard to produce biological agent.
Although the manufacturers of denosumab have not yet released the price of the drug but it is predicted to cost at least $2,000 or more per year which would create a yearly sales of $2billion to $3 billion.
If denosumab is approved, it would be the first drug particularly approved for treating such men, although bisphosphonates have been approved for treating simple osteoporosis.
The two new studies designed and funded by Amgen, had impressive results. The sudies included 7,686 women ages 60 to 90 and 1,468 men being treated for prostate cancer. Many of the patients in these studies reported some side effects which will be a focus of the FDA panel.
"This appears to be the most potent of the osteoporosis drugs," Dr Singer said, "but it will require very careful monitoring to look for rare side effects," which did not show up for other drugs until large numbers of people had received them.












