02.06.2010

Prolia® (Denosumab) auch in den USA zugelassen

FDA Approves Amgen's Prolia(TM) (Denosumab) ...

 

Wie das US-amerikanische Unternehmen AMGEN mitteilt, hat die amerikanische Zulassungsbehörde FDA Prolia auch in den USA zugelassen:

FDA Approves Amgen's Prolia(TM) (Denosumab) for Treatment of Postmenopausal Women With Osteoporosis at High Risk for Fracture

Given As An Injection Every Six Months, Prolia Reduced Risk Of Fracture At The Spine, Hip And Other Sites

THOUSAND OAKS, Calif., June 1, 2010 /PRNewswire via COMTEX/ --Amgen Inc. (Nasdaq: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved Prolia(TM) (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.

Source: http://www.amgen.com

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