Amgen Inc. (Nasdaq: AMGN) today announced that the U.S. Food and Drug Administration (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. Prolia, the first and only FDA-approved RANK Ligand inhibitor, is an every six month 60 mg subcutaneous injection administered by a health care professional.
"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," said Kevin Sharer, chairman of the board and chief executive officer of Amgen. "Prolia is the result of this discovery and offers an important new medicine for postmenopausal women with osteoporosis at high risk for fracture. Amgen is proud to make this new treatment option available to physicians and patients."
Prolia's approval is based on a pivotal three-year Phase 3 study involving 7,808 postmenopausal women with osteoporosis. Treatment with Prolia resulted in greater bone density, stronger bones, and reduced risk for vertebral, hip and non-vertebral fractures measured at three years.
"For the many osteoporosis patients who are at high risk for fracture, Prolia's approval marks the first new class of medicine introduced in nearly a decade," said Felicia Cosman, M.D., clinical director of the National Osteoporosis Foundation and medical director of the Clinical Research Center at Helen Hayes Hospital in New York. "Prolia is a new treatment that reduces the risk of fracture at key sites, including the hip and spine, and is given as a convenient twice-yearly shot just under the skin. It will be a welcome new option."
"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," said Robert A. Bradway, president and chief operating officer of Amgen. "We have priced Prolia responsibly while reflecting its strong therapeutic value and expect to make it commercially available in the U.S. within the next week."
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