Romosozumab Explained

Verifiedfields:changed
Watchedfields:changed
Verifiedrevid:464383486
Type:mab
Mab Type:mab
Source:zu/o
Target:Sclerostin
Tradename:Evenity
Dailymedid:Romosozumab
Pregnancy Au:B3
Atc Prefix:M05
Atc Suffix:BX06
Legal Au:S4
Legal Au Comment:[1] [2]
Legal Ca:Rx-only
Legal Ca Comment:/ Schedule D[3] [4]
Legal Us:Rx-only
Legal Us Comment:[5]
Legal Eu:Rx-only
Legal Eu Comment:[6]
Legal Status:Rx-only
Cas Number:909395-70-6
Drugbank:DB11866
Chemspiderid:none
Unii:3VHF2ZD92J
Kegg:D10156
Synonyms:AMG 785, romosozumab-aqqg
C:6452
H:9926
N:1714
O:2040
S:54

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.

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

The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.[10]

Medical uses

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

Side effects

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

In one trial, more patients in the romosozumab group had serious cardiovascular events compared to the alendronate group (0.8% vs 0.3%),[11] though this was not found in a trial of romosozumab vs placebo.[12] 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. Such a limitation does not exist in Japan.[13] In a large real-world study, prescription of romosozumab was associated with less adverse cardiovascular events compared to other osteoanabolic therapies.[14]

History

Romosozumab was approved for medical use in Japan in January 2019,[15] the United States in April 2019[15] and the European Union in December 2019.[16]

It was originally discovered by Chiroscience,[17] which was acquired by Celltech (now 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]

Notes and References

  1. Web site: 2.4. Romosozumab . Therapeutic Goods Administration (TGA) . 21 June 2022 . 21 May 2024.
  2. Web site: AusPAR: Romosozumab . Therapeutic Goods Administration (TGA) . 21 June 2022 . 21 May 2024.
  3. Web site: Evenity Product information . Health Canada . 25 April 2012 . 29 May 2022.
  4. Web site: Summary Basis of Decision (SBD) for Evenity . . 23 October 2014 . 29 May 2022.
  5. Web site: Evenity- romosozumab-aqqg injection, solution . DailyMed . 30 April 2020 . 21 May 2024.
  6. Web site: Evenity EPAR . European Medicines Agency (EMA) . 9 December 2019 . 21 May 2024.
  7. FDA approves new treatment for osteoporosis in postmenopausal women at high risk of fracture . U.S. Food and Drug Administration (FDA) . 12 April 2019 . 9 April 2019 .
  8. Web site: Drug Trials Snapshot: Evenity . U.S. Food and Drug Administration (FDA) . 26 May 2021 .
  9. Web site: Statement On A Nonproprietary Name Adopted By The USAN Council: Romosozumab. American Medical Association. dead . https://web.archive.org/web/20120929205024/http://www.ama-assn.org/ama1/pub/upload/mm/365/romosozumab.pdf . 29 September 2012.
  10. Web site: New Drug Therapy Approvals 2019 . U.S. Food and Drug Administration (FDA) . 31 December 2019 . 15 September 2020.
  11. Saag KG, Petersen J, Brandi ML, Karaplis AC, Lorentzon M, Thomas T, Maddox J, Fan M, Meisner PD, Grauer A . Romosozumab or Alendronate for Fracture Prevention in Women with Osteoporosis . EN . The New England Journal of Medicine . 377 . 15 . 1417–1427 . October 2017 . 28892457 . 10.1056/nejmoa1708322 . 205102366 . free . 2158/1094968 . free .
  12. Cosman F, Crittenden DB, Adachi JD, Binkley N, Czerwinski E, Ferrari S, Hofbauer LC, Lau E, Lewiecki EM, Miyauchi A, Zerbini CA, Milmont CE, Chen L, Maddox J, Meisner PD, Libanati C, Grauer A . Romosozumab Treatment in Postmenopausal Women with Osteoporosis . EN . The New England Journal of Medicine . 375 . 16 . 1532–1543 . October 2016 . 27641143 . 10.1056/nejmoa1607948 . free .
  13. Stokar J, Szalat A . 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 . May 2024 . 38767110 . 10.1210/clinem/dgae348 .
  14. Stokar J, Szalat A . Cardiovascular Safety of Romosozumab vs. PTH Analogs for Osteoporosis Treatment: a Propensity Score Matched Cohort Study . The Journal of Clinical Endocrinology and Metabolism . March 2024 . 38482603 . 10.1210/clinem/dgae173 . free .
  15. Kaplon H, Muralidharan M, Schneider Z, Reichert JM . Antibodies to watch in 2020 . mAbs . 12 . 1 . 1703531 . 2020 . 31847708 . 6973335 . 10.1080/19420862.2019.1703531 .
  16. News: EC approves treatment for severe osteoporosis postmenopausal women . Rees V . European Pharmaceutical Review . 13 December 2019 . 27 February 2020.
  17. News: Cream of life science entrepreneurs' first venture was selling doughnuts . Quested T . 7 June 2015 . Business Weekly . 24 December 2018 . Q Communications . Cambridge, England .
  18. Winkler DG, Sutherland MK, Geoghegan JC, Yu C, Hayes T, Skonier JE, Shpektor D, Jonas M, Kovacevich BR, Staehling-Hampton K, Appleby M, Brunkow ME, Latham JA . Osteocyte control of bone formation via sclerostin, a novel BMP antagonist . The EMBO Journal . 22 . 23 . 6267–6276 . December 2003 . 14633986 . 291840 . 10.1093/emboj/cdg599 .
  19. Web site: Celltech group Interim Report 2002 . Celltech Group plc .
  20. Book: Sarpal H, Hewitt C, D'Sylva S . Romosozumab for treating severe osteoporosis . Technology appraisal guidance . TA791 . United Kingdom . National Institute for Health and Care Excellence (NICE) . 25 May 2022 . 978-1-4731-4581-8 .

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