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Amgen’s Prolia Gains EU Approval

Amgen has received approval from the EMEA for Prolia (denosumab) for osteoporosis.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Amgen has received approval from the EMEA for Prolia (denosumab) for osteoporosis. The drug’s initial indication will be for women with post-menopausal osteoporosis and men with prostate cancer who, as a result of hormone therapy, are at increased risk of bone fractures. Prolia is administered every six months by injection and is the first in a new class of drugs designed to inhibit proteins that activate bone-destroying cells. The drug is currently under review by the FDA and a decision is ...

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