Drug updated on 9/4/2024
| Dosage Form | Injection (subcutaneous; 105 mg/1.17 mL) |
| Drug Class | Sclerostin inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.
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Summary
- Evenity (romosozumab-aqqg) is indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.
- This summary is based on the review of 19 systematic review(s)/meta-analysis(es). [1-20]
- Romosozumab was effective in reducing clinical fractures, showing superiority over denosumab (OR 1.56, 95% CI 1.02 to 2.39) and bisphosphonates.
- Significant reduction in vertebral fractures was observed with romosozumab compared to placebo, with greater effectiveness than oral bisphosphonates.
- Romosozumab demonstrated superior improvement in bone mineral density (BMD) at the lumbar spine, total hip, and femoral neck, particularly at 6 and 12 months, compared to teriparatide.
- Romosozumab showed the highest effectiveness in reducing non-vertebral and hip fractures at 12 months, with a higher probability of being the most effective among osteoporosis treatments.
- Romosozumab was associated with increased risks of hypersensitivity and injection site reactions, with a comparable overall incidence of adverse events to placebo but fewer total adverse events than alendronate.
- The incidence of serious adverse events with romosozumab was comparable to placebo, with no increased risk of serious adverse events or death compared to teriparatide.
- Romosozumab therapy might increase the risk of 4-point major adverse cardiovascular events (4P MACE) compared to placebo, although no significant increase was observed in the risk of specific cardiovascular outcomes like myocardial infarction or stroke.
- Romosozumab was particularly effective in reducing clinical and vertebral fractures and improving bone mineral density (BMD) in non-Asian postmenopausal women with osteoporosis, and showed significant advantages in treating low BMD and fractures in patients with osteoporotic vertebral compression fractures (OVCF), though it was associated with an increased risk of hypersensitivity and injection site reactions in these populations.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Evenity (romosozumab-aqqg) Prescribing Information. | 2020 | Amgen Inc., Thousand Oaks, CA |