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Amgen's Mixed Advisory Committee Votes On Prolia Still Offer A Good Start

This article was originally published in The Pink Sheet Daily

Executive Summary

The Reproductive Health Drugs Advisory Committee backs Prolia's use to treat osteoporosis in postmenopausal women and bone loss in men undergoing hormone ablation therapy for prostate cancer - though not the largest indication of osteoporosis prevention as well as a REMS.

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New Oncology Indications Should Continue Denosumab’s Upward Trajectory

Already on an upward trajectory in oncology uses, Amgen’s denosumab, known as Prolia and Xgeva, got a bit of a boost with FDA approval of two new indications for treatment-induced bone loss in prostate and breast cancer – though neither is expected to add much to the bottom line.

New Oncology Indications Should Continue Denosumab’s Upward Trajectory

Already on an upward trajectory in oncology uses, Amgen’s denosumab, known as Prolia and Xgeva, got a bit of a boost with FDA approval of two new indications for treatment-induced bone loss in prostate and breast cancer – though neither is expected to add much to the bottom line.

New Oncology Indications Give Amgen's Bone Drug Denosumab A Bit Of A Leg Up

Concerns laid out in "complete response" letter were addressed with data from other trials.

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