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US panel backs Amgen's denosumab for osteoporosis treatment but not prevention

This article was originally published in Scrip

Executive Summary

The US FDA's outside experts have unanimously endorsed approval of Amgen's first-in-class RANK ligand inhibitor Prolia (denosumab) for treatment of postmenopausal osteoporosis (PMO). However, panellists voted 12 to three against a prevention indication, saying they wanted more long-term safety data before clearing use for this broader population.

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