Chemistry:Romosozumab
| 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 |
| License data |
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| Pregnancy category |
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| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| ChemSpider |
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| 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 osteoporosis.[3] 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.[4] 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][5][6]
The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.[7]
Medical uses
Romosozumab is used for osteoporosis to decrease the risk of fractures.[5] 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 denosumab. In the other, one year of romosozumab followed by one year of alendronate had a 50% vertebral fracture reduction compared to two years of alendronate.[5]
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 alendronate group (0.8% vs 0.3%),[8] though this was not found in a trial of romosozumab vs placebo.[9] Currently, the drug contains a boxed warning on its labeling stating that it may increase the risk of heart attack, stroke and cardiovascular death and should not be used in patients who have had a heart attack or stroke within the previous year.[3]
History
Romosozumab was approved for medical use in Japan in January 2019,[5] the United States in April 2019[5] and the European Union in December 2019.[6] It was originally discovered by Chiroscience,[10] which was acquired by Celltech (now[when?] owned by UCB).[11] Celltech entered in a partnership with Amgen in 2002 for the product's development.[12]
UK's NICE provisionally decided not to recommend Romosozumab for use in England and Wales.[13]
References
- ↑ "Evenity Product information". 25 April 2012. https://health-products.canada.ca/dpd-bdpp/info.do?lang=en&code=97967.
- ↑ "Summary Basis of Decision (SBD) for Evenity". 23 October 2014. https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00451&lang=en.
- ↑ 3.0 3.1 3.2 3.3 3.4 3.5 3.6 "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.
- ↑ "Statement On A Nonproprietary Name Adopted By The USAN Council: Romosozumab". American Medical Association. http://www.ama-assn.org/ama1/pub/upload/mm/365/romosozumab.pdf.
- ↑ 5.0 5.1 5.2 5.3 5.4 "Antibodies to watch in 2020". mAbs 12 (1): 1703531. 2020. doi:10.1080/19420862.2019.1703531. PMID 31847708.
- ↑ 6.0 6.1 "EC approves treatment for severe osteoporosis postmenopausal women". European Pharmaceutical Review. 13 December 2019. https://www.europeanpharmaceuticalreview.com/news/107970/ec-approves-treatment-for-severe-osteoporosis-postmenopausal-women/.
- ↑ "New Drug Therapy Approvals 2019". 31 December 2019. https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/new-drug-therapy-approvals-2019.
- ↑ "Romosozumab or Alendronate for Fracture Prevention in Women with Osteoporosis" (in EN). The New England Journal of Medicine 377 (15): 1417–1427. October 2017. doi:10.1056/nejmoa1708322. PMID 28892457.
- ↑ "Romosozumab Treatment in Postmenopausal Women with Osteoporosis" (in EN). The New England Journal of Medicine 375 (16): 1532–1543. October 2016. doi:10.1056/nejmoa1607948. PMID 27641143.
- ↑ "Cream of life science entrepreneurs' first venture was selling doughnuts". Business Weekly (Cambridge, England: Q Communications). 7 June 2015. https://www.businessweekly.co.uk/news/cambridge-torchbearers/cream-life-science-entrepreneurs%E2%80%99-first-venture-was-selling-doughnuts.
- ↑ "Osteocyte control of bone formation via sclerostin, a novel BMP antagonist". The EMBO Journal 22 (23): 6267–6276. December 2003. doi:10.1093/emboj/cdg599. PMID 14633986.
- ↑ "Celltech group Interim Report 2002". Celltech Group plc. http://media.corporate-ir.net/media_files/LSE/CLL.UK/reports/interim2002.pdf.
- ↑ "NHS medics call for osteoporosis drug to be recommended in England and Wales". Evening Standard. 2 January 2022. https://www.standard.co.uk/news/uk/national-institute-for-health-and-care-excellence-england-wales-nhs-sunday-times-b974645.html.
External links
- "Romosozumab". Drug Information Portal. U.S. National Library of Medicine. https://druginfo.nlm.nih.gov/drugportal/name/romosozumab.
- "Drug Trials Snapshot: Evenity". 26 May 2021. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshot-evenity.
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