Drug updated on 4/18/2024
| 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.
Summary
- Romosozumab-aqqg (Evenity) is indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture. This includes those with a history of osteoporotic fracture, multiple risk factors for fracture, or those who have failed or are intolerant to other available osteoporosis therapy.
- Nineteen systematic reviews and meta-analyses provide information on the comparative effectiveness, safety profiles, and subgroup considerations related to Evenity.
- Evenity has consistently shown its ability to reduce the risk of clinical, vertebral, and non-vertebral fractures in postmenopausal women compared with placebo, bisphosphonates such as alendronate, denosumab, and teriparatide.
- Romosozumab-aqqg increases bone mineral density (BMD) at the lumbar spine, total hip, and femoral neck within 12 months more effectively than bisphosphonates. It is comparable or superior to denosumab and teriparatide, depending on outcome measures.
- Analysis of the safety profile relative to other treatments indicates a generally favorable profile. However, it does show increased risks of hypersensitivity reactions and injection site reactions but lower overall adverse events compared to alendronate.
- Although some evidence suggests an increased risk of cardiovascular adverse events compared to placebo and other treatments from one study, the overall evidence suggests that these rates are within an acceptable range considering the benefits offered by this drug.
- The effectiveness in increasing BMD and reducing fracture risks does not seem significantly affected by baseline indicators, thus indicating broad applicability across varying degrees of severity among postmenopausal populations suffering from osteoporosis.
- Evidence also points towards notable efficacy among population groups who have previously failed or are intolerant towards existing therapies, thereby highlighting its role as an alternative treatment option.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Evenity (romosozumab-aqqg) Prescribing Information. | 2020 | Amgen Inc., Thousand Oaks, CA |