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news.Amgen said that FDA has approved Prolia (denosumab) 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.
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According to Amgen, Prolia’s approval is based on a pivotal three-year Phase 3 study involving 7,808 postmenopausal women with osteoporosis.
Amgen claimed that Prolia, the first and only FDA-approved RANK Ligand inhibitor, is an every six month 60mg subcutaneous injection administered by a health care professional.
Reportedly, treatment with Prolia resulted in better bone density, stronger bones, and reduced risk for vertebral, hip and non-vertebral fractures measured at three years.
Kevin Sharer, chairman of the board and CEO of Amgen, said: “Today’s FDA approval of Prolia is the culmination of a scientific journey that started more than 15 years ago with Amgen’s discovery of an essential pathway that regulates bone metabolism.”
Robert Bradway, president and COO of Amgen, said: “While this is an important milestone for Amgen, it is even more important for the postmenopausal patients with osteoporosis who are at high risk for fracture. We have priced Prolia responsibly while reflecting its strong therapeutic value and expect to make it commercially available in the US within the next week.”