Amgen Inc., the world's largest biotechnology company has asked the Food and Drug Administration for approval of experimental drug denosumab as a treatment for osteoporosis in post- menopausal women.
The drug Denosumab is aimed at preventing and treating osteoporosis in post menopausal women and for patients undergoing breast or prostate cancer treatment.
An Amgen spokeswoman said the company would find out from the FDA within 60-75 days once the agency’s review concludes. Under a standard review the FDA tries to make its decision within 10 months from the date of submission.
The company said a large trial of the drug denosumab in September on post menopausal women who were suffering from osteoporosis had a reduced risk of some spine fractures by about 68 %.
Analysts are touting the drug to possibly be the next blockbuster for the company which has seen slack of its anemia drugs after the emergence of data two years ago showing the drugs raised the risk of death for some cancer patients. Amgen’s shares have been on the rise since the middle of the year riding on the waves of positive study results of denosumab.
Amgen said it hoped to ask for European approval soon.
Global sales for osteoporosis treatments in 2007 exceeded $8.9 billion for drugs including Fosamax, Boniva, Actonel and Reclast.












