Global InformationRomosozumab information
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Humanized (from mouse) |
| Target | Sclerostin |
| Clinical data | |
| Trade names | Evenity |
| Other names | AMG 785, romosozumab-aqqg |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a619026 |
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| Chemical and physical data | |
| Formula | C6452H9926N1714O2040S54 |
| Molar mass | 145877.58 g·mol−1 |
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Romosozumab, sold under the brand name Evenity, is a medication used to treat osteoporosis.[3][4] It has been found to decrease the risk of fractures of the spine.[3]
Common side effects include headache, joint pain, and injection site reactions including pain.[3] It may increase the risk of heart attacks, strokes, and deaths from cardiovascular disease.[3] It is a humanized monoclonal antibody that targets sclerostin.[5] Research shows the drug increases bone formation and decreases bone resorption in postmenopausal women with low bone density. Romosozumab was approved for medical use in Japan, the United States and the European Union in 2019.[3][6][7]
The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.[8]
- ^ "Evenity Product information". Health Canada. 25 April 2012. Retrieved 29 May 2022.
- ^ "Summary Basis of Decision (SBD) for Evenity". Health Canada. 23 October 2014. Retrieved 29 May 2022.
- ^ a b c d e "FDA approves new treatment for osteoporosis in postmenopausal women at high risk of fracture". U.S. Food and Drug Administration (FDA) (Press release). 9 April 2019. Retrieved 12 April 2019.
- ^ "Drug Trials Snapshot: Evenity". U.S. Food and Drug Administration (FDA). 26 May 2021.
- ^ "Statement On A Nonproprietary Name Adopted By The USAN Council: Romosozumab" (PDF). American Medical Association. Archived from the original (PDF) on 29 September 2012.
- ^ Cite error: The named reference
pmid31847708was invoked but never defined (see the help page). - ^ Cite error: The named reference
Reeswas invoked but never defined (see the help page). - ^ "New Drug Therapy Approvals 2019". U.S. Food and Drug Administration. 31 December 2019. Retrieved 15 September 2020.