Amgen's Evenity Clears US FDA With Preferred Indication, Black Box Warning
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.
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Redacted drug approval packages highlight key issues in US FDA quality reviews of Amgen’s Evenity, Jazz’s Sunosi and Novartis’ Mayzent.
Evenity's Postmarketing Requirement Includes Feasibility Component Familiar To Other Osteoporosis Drugs
Amgen might have to conduct a randomized CV outcomes trial for Evenity if it's possible; a Pink Sheet analysis reveals that feasibility has been a factor in the US FDA's postmarketing requirements and commitments for other osteoporosis drugs as well.
Evenity Likely Headed For Approval With Amgen's Proposed Indication, But Postmarketing Requirements Remain Unclear
US FDA advisory committee splits on whether Amgen's osteoporosis drug romosozumab needs observational study or randomized controlled trial to assess cardiovascular risks.