ARCH CV Signal Scuppers Blockbuster Hopes For Amgen/UCB's Evenity
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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Amgen EVP Murdo Gordon highlighted the unmet need for women at high risk, including those with a prior fracture. At $1,825 per month or $21,900 for a one-year course in the US, he says Evenity's cost is much lower versus competing 18- and 24-month anabolic agents.
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.
Narrower indication and a boxed warning for Amgen's osteoporosis drug romosozumab might be sufficient to permit approval.