Amgen Puts Evenity Filing Back On Track With TIMI Cardiovascular Risk Review
As Amgen’s main hope for extending its bone health franchise, romosozumab faces a second review at the FDA with a fuller dataset and an external analysis of cardiovascular risk.
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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.
The latest group of new product approvals in Japan includes the first marketing clearances worldwide for fracture-reducing osteoporosis antibody romosozumab and a stem cell-based therapy for spinal cord injury, as well as two new Daiichi drugs and Pfizer's lung cancer therapy dacomitinib.
Narrower indication and a boxed warning for Amgen's osteoporosis drug romosozumab might be sufficient to permit approval.