Romosozumab

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Romosozumab
Monoclonal antibody
TypeWhole antibody
SourceHumanized (from mouse)
TargetSclerostin
Names
Trade namesEvenity
Other namesAMG 785, romosozumab-aqqg
Clinical data
Main usesOsteoporosis[1]
Side effectsHeadache, joint pain, allergic reaction[2]
Pregnancy
category
  • AU: B3
  • US: N (Not classified yet)
Typical dose210 mg[1]
External links
AHFS/Drugs.comMonograph
MedlinePlusa619026
Legal
License data
Legal status
  • AU: S4 (Prescription only)
  • US: ℞-only
  • EU: Rx-only
  • In general: ℞ (Prescription only)
Chemical and physical data
FormulaC6452H9926N1714O2040S54
Molar mass145877.58 g·mol−1

Romosozumab, sold under the brand name Evenity, is a medication used to treat osteoporosis.[1] It decreases the risk of fractures of the spine.[1] It is used by injection under the skin.[1]

Common side effect include headache, joint pain, and allergic reactions.[2] It may increase the risk of heart attacks and strokes.[3] Other side effects may include low calcium.[1] It is a monoclonal antibody that attaching to and blocks sclerostin.[1] This increases bone formation and reduces bone breakdown.[1]

Romosozumab was approved for medical use in the United States and Europe in 2019.[1][3] In the United States it costs about $2,050 a month as of 2021.[4] This amount in the United Kingdom costs the NHS about £430.[2]

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]

Dosage

It is used at a dose of 210 mg once a month for up to a year.[1]

Side effects

Common side effects include headache, joint pain, and pain at the site of injection.[6] It may increase the risk of heart attacks, strokes, and deaths from cardiovascular disease.[6]

Mechanism of action

Mechanism of romosozumab[7]

Romosozumab inhibits sclerostin from inhibiting bone formation which it usually does via binding to LDL receptor-related proteins 5/6 of osteoblasts. As a consequence, Romosozumab permits Wnt signaling in osteoblasts which promotes bone formation [7]

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.[8] It was originally discovered by Chiroscience,[9] which was acquired by Celltech (now[when?] owned by UCB).[10] Celltech entered in a partnership with Amgen in 2002 for the product's development.[11]

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

References

  1. ↑ 1.0 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8 1.9 "Evenity". Archived from the original on 7 January 2021. Retrieved 18 October 2021.
  2. ↑ 2.0 2.1 2.2 BNF (80 ed.). BMJ Group and the Pharmaceutical Press. September 2020 – March 2021. p. 776. ISBN 978-0-85711-369-6.
  3. ↑ 3.0 3.1 "Romosozumab-aqqg Monograph for Professionals". Drugs.com. Retrieved 18 October 2021.
  4. ↑ "Evenity Prices, Coupons & Patient Assistance Programs". Drugs.com. Archived from the original on 19 April 2021. Retrieved 18 October 2021.
  5. ↑ 5.0 5.1 5.2 5.3 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.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  6. ↑ 6.0 6.1 "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. Archived from the original on 2 May 2019. Retrieved 12 April 2019.
  7. ↑ 7.0 7.1 Lim, Sian Yik; Bolster, Marcy B. (13 April 2017). "Profile of romosozumab and its potential in the management of osteoporosis". Drug Design, Development and Therapy. 11: 1221–1231. doi:10.2147/DDDT.S127568. Archived from the original on 28 September 2022. Retrieved 13 February 2024.
  8. ↑ Victoria Rees (13 December 2019). "EC approves treatment for severe osteoporosis postmenopausal women". European Pharmaceutical Review. Archived from the original on 28 February 2020. Retrieved 27 February 2020.
  9. ↑ Quested T (7 June 2015). "Cream of life science entrepreneurs' first venture was selling doughnuts". Business Weekly. Cambridge, England: Q Communications. Archived from the original on 24 December 2018. Retrieved 24 December 2018.
  10. ↑ 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.
  11. ↑ "Celltech group Interim Report 2002" (PDF). Celltech Group plc. Archived (PDF) from the original on 19 February 2019. Retrieved 24 July 2021.
  12. ↑ "New Drug Therapy Approvals 2019". U.S. Food and Drug Administration. 31 December 2019. Archived from the original on 16 September 2020. Retrieved 15 September 2020.

External links

External sites:
Identifiers:
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