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FDA Approves Amgen’s Prolia

Amgen received approval from the FDA for Prolia (denosumab) for the treatment of postmenopausal women with osteoporosis at high risk for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Amgen received approval from the FDA for Prolia (denosumab) for the treatment of postmenopausal women with osteoporosis at high risk for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. Prolia, administered every six months by subcutaneous injection, is the first FDA-approved RANK Ligand inhibitor.

The approval is based on a Phase III study in 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.

“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 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.”

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