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FDA Approves New Injectable Osteoporosis Treatment for Postmenopausal Women
Date:6/1/2010

SILVER SPRING, Md., June 1 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Prolia, an injectable treatment for postmenopausal women with osteoporosis who are at high risk for fractures.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO )

Osteoporosis is a disease in which the bones become weak and are more likely to break. According to the National Institute of Arthritis and Musculoskeletal and Skin Diseases, 80 percent of the people in the United States with osteoporosis are women. One out of every two women over age 50 will break a bone in their lifetime due to osteoporosis.

People with osteoporosis at high risk for fracture include those that have had an osteoporotic fracture, or have multiple risk factors for fracture; or those who have failed or are intolerant to other available osteoporosis therapy. Prolia works to decrease the destruction of bone and increase bone mass and strength. An injection of Prolia is recommended once every six months.

"Due to its prevalence, osteoporosis is a serious concern to public health," said Julie Beitz, M.D., director of the FDA's Office of Drug Evaluation III. "The approval of Prolia provides another treatment option for postmenopausal women with osteoporosis who are susceptible to fractures."

The safety and efficacy of Prolia in the treatment of postmenopausal osteoporosis was demonstrated in a three-year, randomized, double-blind,
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SOURCE U.S. Food and Drug Administration
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