Second time's a charm for osteoporosis drug from Amgen, UCB as FDA panel grants its blessing
Looks like Amgen and UCB’s osteoporosis drug is headed to the finish line, after an FDA panel largely supported its approval on Wednesday. But if approved, it will likely carry a black box warning advising against its use in patients with high cardiovascular risk.
The recommendation follows a rosy review from FDA staff posted on Monday, who underscored romosozumab’s efficacy in postmenopausal women with a high risk of fracture had been established, and suggested that the CV signal observed in some trials may not be a significant worry. An independent panel of experts whose recommendations the FDA typically follows endorsed the drug, in light of its efficacy in patients that usually have few treatment options, but suggested the CV risk be characterized post approval.
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