ARCH CV Signal Scuppers Blockbuster Hopes For Amgen/UCB's Evenity
Executive Summary
New Phase III data for the novel osteoporosis therapy romosozumab are set to delay its approval, reduce its commercial potential and open the market to rivals.
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Osteoporosis treatment romosozumab-aqqg indicated for postmenopausal women at high risk for fracture; advisory committee appears to have help persuade FDA that a black box would be sufficient to manage cardiovascular risk rather than a narrower indication.
Amgen's Evenity Faces CV Safety Gauntlet At US FDA Advisory Cmte.
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