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FDA Okays Amgen's Prolia, But With Hefty Post-Marketing Requirements In Tow

This article was originally published in The Pink Sheet Daily

Executive Summary

Denosumab will be indicated for use in postmenopausal women with osteoporosis who are at high risk for fractures.

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Amgen Obtains Broader Label For Denosumab With Oncology Indication

FDA approved Amgen’s bone-strengthening drug denosumab Nov. 18 for its first oncology indication, prevention of skeletal-related events – bone fractures or bone pain requiring radiation treatment – in patients with bone metastases from solid tumors.

Amgen Obtains Broader Label For Denosumab With Oncology Indication

FDA approved Amgen’s bone-strengthening drug denosumab Nov. 18 for its first oncology indication, prevention of skeletal-related events – bone fractures or bone pain requiring radiation treatment – in patients with bone metastases from solid tumors.

FDA Approves Amgen's Denosumab For First Oncology Indication

Known as Prolia for osteoporosis, the drug will be called Xgeva for skeletal-related events related to metastasized solid-tumor cancers.

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