Overview
Romosozumab is a humanized monoclonal antibody indicated for the treatment of osteoperosis in postmenopausal women at high risk of fracture and patients who have failed in other treatments or are intolerant to other osteoperosis therapies. Romosozumab prevents bone resorption and induces the formation of bone though it is associated with an increased risk of cardiac death, heart attack, and stroke in one study. In a comparison study of post menopausal women with osteoporosis and a past fracture, romosozumab for 12 months followed by alendronic acid for 12 months was superior to alendronic acid alone for 24 months. Romosozumab also demonstrates a faster and larger increase in bone density than teriparatide. Romosozumab is marketed in the United States by Amgen under the brand name Evinity. Romosozumab was granted FDA approval on April 9,2019.
Indication
Romosozumab is indicated for the treatment of osteoporosis in post menopausal women at high risk of fractures and also in patients with osteoperosis who are intolerant to other treatments or who have failed in other treatments.
Associated Conditions
- Osteoporosis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/05/15 | Phase 2 | Not yet recruiting | Nitin Agarwal | ||
2024/12/06 | Phase 4 | Not yet recruiting | |||
2024/08/16 | Phase 4 | Recruiting | |||
2024/08/01 | Phase 3 | Recruiting | |||
2024/06/24 | Phase 4 | Recruiting | |||
2023/12/11 | N/A | Recruiting | |||
2023/10/12 | Phase 4 | Active, not recruiting | |||
2023/09/28 | Phase 4 | Recruiting | |||
2023/08/02 | Phase 3 | Recruiting | |||
2023/03/20 | Phase 1 | Active, not recruiting |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 12/9/2019 | ||
Authorised | 12/9/2019 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
EVENITY SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 105 MG/1.17 ML | SIN16208P | INJECTION, SOLUTION | 105 mg/1.17 mL | 5/27/2021 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
EVENITY romosozumab 105 mg/1.17 mL injection solution syringe | 296831 | Medicine | A | 7/1/2019 | |
EVENITY romosozumab 105 mg/1.17 mL injection solution syringe with a pen injector | 296830 | Medicine | A | 7/1/2019 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
EVENITY | Amgen Canada Inc | 02489597 | Solution - Subcutaneous | 105 MG / 1.17 ML | 8/12/2019 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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