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Romosozumab

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Romosozumab
Monoclonal antibody
TypeWhole antibody
SourceHumanized (from mouse)
TargetSclerostin
Clinical data
Trade namesEvenity
Other namesAMG 785, romosozumab-aqqg
AHFS/Drugs.comMonograph
MedlinePlusa619026
License data
Pregnancy
category
  • AU: B3
ATC code
Legal status
Legal status
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
Chemical and physical data
FormulaC6452H9926N1714O2040S54
Molar mass145877.58 g·mol−1
 ☒NcheckY (what is this?)  (verify)

Romosozumab, sold under the brand name Evenity, is a medication used to treat osteoporosis.[7][8] It has been found to decrease the risk of fractures of the spine.[7]

Common side effects include headache, joint pain, and injection site reactions including pain.[7] It may increase the risk of heart attacks, strokes, and deaths from cardiovascular disease.[7] It is a humanized monoclonal antibody that targets sclerostin.[9] 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.[7][10][11]

The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.[12]

Medical uses

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Romosozumab is used for osteoporosis to decrease the risk of fractures.[10] 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.[10]

Side effects

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Common side effects include headache, joint pain, and injection site reactions including pain.[7]

In one trial, more patients in the romosozumab group had serious cardiovascular events compared to the alendronate group (0.8% vs 0.3%),[13] though this was not found in a trial of romosozumab vs placebo.[14] Currently, the drug contains a FDA 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.[7] Such a limitation does not exist in Japan.[15] In a large real-world study, prescription of romosozumab was associated with less adverse cardiovascular events compared to other osteoanabolic therapies.[16]

History

[edit]

Romosozumab was approved for medical use in Japan in January 2019,[10] the United States in April 2019[10] and the European Union in December 2019.[11]

It was originally discovered by Chiroscience,[17] which was acquired by Celltech (now[when?] owned by UCB).[18] Celltech entered in a partnership with Amgen in 2002 for the product's development.[19]

The UK's National Institute for Health and Care Excellence (NICE) decided to recommend romosozumab for use in England and Wales.[20]

References

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  1. ^ "2.4. Romosozumab". Therapeutic Goods Administration (TGA). 21 June 2022. Retrieved 21 May 2024.
  2. ^ "AusPAR: Romosozumab". Therapeutic Goods Administration (TGA). 21 June 2022. Retrieved 21 May 2024.
  3. ^ "Evenity Product information". Health Canada. 25 April 2012. Retrieved 29 May 2022.
  4. ^ "Summary Basis of Decision (SBD) for Evenity". Health Canada. 23 October 2014. Retrieved 29 May 2022.
  5. ^ "Evenity- romosozumab-aqqg injection, solution". DailyMed. 30 April 2020. Retrieved 21 May 2024.
  6. ^ "Evenity EPAR". European Medicines Agency (EMA). 9 December 2019. Retrieved 21 May 2024.
  7. ^ 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.
  8. ^ "Drug Trials Snapshot: Evenity". U.S. Food and Drug Administration (FDA). 26 May 2021.
  9. ^ "Statement On A Nonproprietary Name Adopted By The USAN Council: Romosozumab" (PDF). American Medical Association. Archived from the original (PDF) on 29 September 2012.
  10. ^ a b c d e Kaplon H, Muralidharan M, Schneider Z, Reichert JM (2020). "Antibodies to watch in 2020". mAbs. 12 (1): 1703531. doi:10.1080/19420862.2019.1703531. PMC 6973335. PMID 31847708.
  11. ^ a b Rees V (13 December 2019). "EC approves treatment for severe osteoporosis postmenopausal women". European Pharmaceutical Review. Retrieved 27 February 2020.
  12. ^ "New Drug Therapy Approvals 2019". U.S. Food and Drug Administration (FDA). 31 December 2019. Retrieved 15 September 2020.
  13. ^ Saag KG, Petersen J, Brandi ML, Karaplis AC, Lorentzon M, Thomas T, et al. (October 2017). "Romosozumab or Alendronate for Fracture Prevention in Women with Osteoporosis". The New England Journal of Medicine. 377 (15): 1417–1427. doi:10.1056/nejmoa1708322. hdl:2158/1094968. PMID 28892457. S2CID 205102366.
  14. ^ Cosman F, Crittenden DB, Adachi JD, Binkley N, Czerwinski E, Ferrari S, et al. (October 2016). "Romosozumab Treatment in Postmenopausal Women with Osteoporosis". The New England Journal of Medicine. 375 (16): 1532–1543. doi:10.1056/nejmoa1607948. PMID 27641143.
  15. ^ Stokar J, Szalat A (May 2024). "Response to Letter to the Editor from Kawaguchi: 'Cardiovascular Safety of Romosozumab vs. PTH Analogs for Osteoporosis Treatment: a Propensity Score Matched Cohort Study". The Journal of Clinical Endocrinology and Metabolism. doi:10.1210/clinem/dgae348. PMID 38767110.
  16. ^ Stokar J, Szalat A (March 2024). "Cardiovascular Safety of Romosozumab vs. PTH Analogs for Osteoporosis Treatment: a Propensity Score Matched Cohort Study". The Journal of Clinical Endocrinology and Metabolism. doi:10.1210/clinem/dgae173. PMID 38482603.
  17. ^ 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.
  18. ^ Winkler DG, Sutherland MK, Geoghegan JC, Yu C, Hayes T, Skonier JE, et al. (December 2003). "Osteocyte control of bone formation via sclerostin, a novel BMP antagonist". The EMBO Journal. 22 (23): 6267–6276. doi:10.1093/emboj/cdg599. PMC 291840. PMID 14633986.
  19. ^ "Celltech group Interim Report 2002" (PDF). Celltech Group plc.
  20. ^ Sarpal H, Hewitt C, D'Sylva S (25 May 2022). Romosozumab for treating severe osteoporosis. Technology appraisal guidance. United Kingdom: National Institute for Health and Care Excellence (NICE). ISBN 978-1-4731-4581-8. TA791.
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