Romosozumab Reference

Plain English

What it is

Romosozumab, sold under the brand name Evenity, is an FDA-approved prescription medicine. It is a lab-made antibody that blocks a protein called sclerostin, and it is the only approved bone drug that both builds new bone and slows bone breakdown at the same time.

What people use it for

It is approved to treat osteoporosis, which means weak, thinning bones, in women who have gone through menopause and have a high chance of breaking a bone. It is given as a shot under the skin for a limited time, after which people usually switch to a different bone medicine.

What the science shows

In large studies of women after menopause, it lowered the risk of broken bones. One big trial compared it to a placebo (a dummy shot) and another compared it to a common bone medicine, and both showed fewer fractures with romosozumab.

The catch

It carries a boxed warning, the strongest kind of FDA warning, for a higher risk of heart attack, stroke, and death from heart problems. It should not be started in someone who has had a heart attack or stroke within the past year, and it is a prescription medicine, not a research chemical.

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

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