Monday, October 19, 2009
Amgen Gets Delay On Osteoporosis Treatment
The Food and Drug Adminstration has delayed an approval of Thousand Oaks-based Amgen's osteoporosis denosumab, the firm said Monday, in order to seek more information. According to Amgen, the FDA has requested that the firm include further information on the design of its previously submitted post-marketing surveillance program. Amgen said it will work with the FDA to determine the appropriate next steps regarding the applications. The compound is being targeted at treatment and prevention of postmenopausal osteoporosis, as well as bone loss in breast and prostate cancer patients due to hormone ablation therapy.