The Thousand Oaks, California based biotechnology company, Amgen Inc., which is basically involved in the manufacture of drugs that augment the blood, now plans to bring forth data related to a new drug – ‘denosumab’ - that can strengthen bones.

Amgen has pinned a lot of hopes on this drug, which can also boost up its own growth prospects. The company is planning to file an application for approval of ‘denosumab’ to the Food and Drug Administration by the end of the year, and has great hope that the drug will be duly approved.

Presenting 25 different reports on the drug at a meeting of the American Society for Bone Mineral Research, Montreal, Amgen researchers claimed that the drug can ward off osteoporosis. The company has said clinical trials indicate ‘denosumab’ can not only improve bone-mineral density, but can also reduce hip, spinal and other fractures that afflict people suffering from osteoporosis.

To osteoporosis patients, Denosumab is given as an injection just under the skin every six months, with Fosamax, a drug from Merck & Co. In America, there are nearly 10 million people affected by this bone-weakening disease, 80% of whom are post-menopausal women.  

In a study, out of the 504 postmenopausal women with osteoporosis, one half who got shots of Denosumab showed 2 per cent increase in bone density after a year, as compared to the other half who showed 1 percent increase after shots of Fosamax.

Despite such studies, the fact that very little is known about ‘denosumab’ in terms of its long-term safety can be a potential stumbling block for its approval by FDA. Doctors and analysts do not have clear information on two basic things – firstly, how Amgen will price the drug, and secondly, whether or not the patients will go in for twice-yearly shots as against the present drugs being taken once a week or once a month, or a yearly infusion.