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Prolia™ (denosumab) Receives Best New Drug Honor at Scrip Awards
Date:11/5/2010

rovement of healthcare. For more information, visit the Scrip website http://www.scripintelligence.com/awards/

About ProliaProlia is approved for use in the U.S., the EU, Canada, Australia and Switzerland. In the U.S., Prolia is approved for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, Prolia reduces the incidence of vertebral, non-vertebral and hip fractures. The U.S. prescribing information indicates Prolia should be administered by a healthcare professional.

The pivotal three-year Phase 3 Fracture REduction Evaluation of Denosumab in Osteoporosis every six Months (FREEDOM) study in 7,808 women with postmenopausal osteoporosis demonstrated that Prolia, administered as a 60mg subcutaneous injection every six months, compared with placebo at three years resulted in:(vi)

  • A 68 percent reduction in vertebral fractures (4.8 percent absolute risk reduction). The incidence of new spine fractures was 2.3 percent with Prolia vs. 7.2 percent with placebo;
  • A 40 percent reduction in hip fractures (0.3 percent absolute risk reduction). The incidence of hip fractures was 0.7 percent with Prolia vs. 1.2 percent with placebo;
  • A 20 percent reduction in non-vertebral fractures (1.5 percent absolute risk reduction). The incidence of non-spine fractures was 6.5 percent with Prolia vs. 8 percent with placebo;
  • Significant bone density increases at all key sites measured (8.8 percent at the lumbar spine, 6.4 percent at the total hip, and 5.2 percent at the femoral neck).

  • In the EU, Prolia is approved for the treatment of osteoporosis in postmenopausal women at increased risk of fractures, and for the treatment of bone los
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    SOURCE Amgen
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