Amgen's Prolia (Denosumab) Granted Marketing Authorization in the European Union
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Amgen Inc. announced that the European Commission (EC) has granted marketing authorization for Prolia® (denosumab) for the treatment of osteoporosis in postmenopausal women at increased risk of fractures, and for the treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. Prolia has been approved in all 27 European Union member states plus Norway, Iceland and Liechtenstein. The European approval of Prolia marks the first approval of the product worldwide.
"The European approval of Prolia is a significant medical advance for patients with bone loss conditions," said Will Dere, senior vice president and international chief medical officer at Amgen. "In particular, we believe that Prolia will offer patients with postmenopausal osteoporosis at increased risk for fracture an important alternative to current treatments. Prolia reduces the risk of fracture through a convenient injection given every six months. Amgen is proud to make this new treatment available to physicians and their patients."
The marketing authorization for Prolia comprises data from six Phase 3 trials, including two pivotal Phase 3 studies with fracture endpoints in the osteoporosis and prostate cancer settings, which demonstrated that Prolia administered as a 60mg subcutaneous injection every six months reduces the incidence of fractures. All six studies showed Prolia’s ability to increase bone mineral density (a measure of bone strength) at all skeletal sites measured.
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