Romosozumab
Humanized (from mouse) | |
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Target | Sclerostin |
Clinical data | |
Trade names | Evenity |
Other names | AMG 785, romosozumab-aqqg |
AHFS/Drugs.com | Monograph |
MedlinePlus | a619026 |
License data | |
Pregnancy category |
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ATC code | |
Legal status | |
Legal status | |
Identifiers | |
CAS Number | |
DrugBank | |
ChemSpider |
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UNII | |
KEGG | |
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
Common side effects include headache, joint pain, and
The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.[8]
Medical uses
Romosozumab is used for osteoporosis to decrease the risk of fractures.[6] Two trials found that it reduced the rate of vertebral fracture. In one, there was a 73% lower risk of vertebral fracture after one year, and the benefit was maintained after a second year of taking
Side effects
Common side effects include headache, joint pain, and injection site reactions including pain.[3]
In one trial, more patients in the romosozumab group had serious cardiovascular events compared to the
History
Romosozumab was approved for medical use in Japan in January 2019,[6] the United States in April 2019[6] and the European Union in December 2019.[7]
It was originally discovered by Chiroscience,[12] which was acquired by Celltech (now[when?] owned by UCB).[13] Celltech entered in a partnership with Amgen in 2002 for the product's development.[14]
The UK's National Institute for Health and Care Excellence (NICE) provisionally decided not to recommend romosozumab for use in England and Wales.[15]
References
- ^ "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 f g "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.
- ^ PMID 31847708.
- ^ a b Rees V (13 December 2019). "EC approves treatment for severe osteoporosis postmenopausal women". European Pharmaceutical Review. Retrieved 27 February 2020.
- ^ "New Drug Therapy Approvals 2019". U.S. Food and Drug Administration. 31 December 2019. Retrieved 15 September 2020.
- S2CID 205102366.
- PMID 27641143.
- .
- ^ Quested T (7 June 2015). "Cream of life science entrepreneurs' first venture was selling doughnuts". Business Weekly. Cambridge, England: Q Communications. Retrieved 24 December 2018.
- PMID 14633986.
- ^ "Celltech group Interim Report 2002" (PDF). Celltech Group plc.
- ^ Parnaby L (2 January 2022). "NHS medics call for osteoporosis drug to be recommended in England and Wales". Evening Standard.