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Romosozumab Reference

Educational, not medical advice reference for Romosozumab: Bone; regulatory status, evidence posture, source review, and schedule notes. Also kn…

Reference summary

Romosozumab is label-verified. The pivotal program is FRAME (Cosman 2016 NEJM, PMID 27641143, romosozumab vs placebo for 12 months followed by denosumab) and ARCH (Saag 2017 NEJM, PMID 28892457, romosozumab followed by alendronate vs alendronate alone, head-to-head against an active comparator). The boxed cardiovascular warning emerged from the ARCH trial cardiovascular adjudication. pepSmart surfaces label-reference content only and is not a prescribing tool.

Regulatory and posture

Categories
Bone
Aliases
Romosozumab-aqqg, Evenity, Anti-sclerostin monoclonal antibody
Evidence posture
human - Boxed warning for cardiovascular events (MI, stroke, CV death). Prescribing is restricted to women with osteoporosis at high fracture risk. Do not initiate within one year of a recent MI or stroke. Treatment limited to 12 monthly doses.
Regulatory status
FDA-approved prescription medication (April 2019) for the treatment of postmenopausal women with osteoporosis at high risk for fracture. The label carries a BOXED WARNING for increased risk of myocardial infarction, stroke, and cardiovascular death; the drug must not be initiated in patients who have had a myocardial infarction or stroke within the preceding year. Co-developed by Amgen and UCB. Anti-sclerostin monoclonal antibody.
Content review status
label verified

Selected public sources

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