Amgen Inc, the world's largest biotechnology company, said on Friday it filed for US Food and Drug Administration approval of experimental drug denosumab as a treatment for osteoporosis in post- menopausal women. The application also covers treatment and prevention of bone loss in patients undergoing hormone ablation for either prostate or breast cancer.
An Amgen spokeswoman said the company will find out from the FDA within 60 to 75 days when the agency's review is expected to conclude. Denosumab is viewed as the next key growth engine at Amgen, which has seen sales of its flagship anemia drugs slide after the emergence of data two years ago showing the drugs raised the risk of death for some cancer patients.
The Thousand Oaks, California-based company said in September that a large trial of denosumab in post-menopausal women suffering from osteoporosis showed it reduced the risk of some spine fractures by about 68 percent. The company is also developing the drug as a treatment for cancer patients. Amgen said pivotal cancer data will become available on a rolling basis starting next year. The company's shares were unchanged after hours at $57.83.