Processing Magazine

FDA Approves Amgen''s Drug Prolia

June 2, 2010
According to the Associated Press, the Food and Drug Administration approved Amgen''s bone strengthening drug, Prolia, for postmenopausal women at risk for fractures, a potential blockbuster market. The injectable drug is given once every six months to increase bone mass and strength. Analysts think Prolia should bring Amgen billions in revenue after it is launched. Sales of the company''s former top sellers, the anemia drugs, Aranesp and Epogen, have dropped in recent years due to safety concerns and label restrictions. An analysis cited by Amgen estimates that osteoporosis-related fractures will cost the U.S. health care system $25 billion annually by 2025. FDA approved the drug based on a 7,000 patient study conducted by Amgen that showed reduced vertebrae and hip fractures in postmenopausal women.