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
US NLMRomosozumab
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
 ☒NcheckY (what is this?)  (verify)

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]

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

The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.[11]

References

  1. 1.0 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8 1.9 "Evenity". Retrieved 18 October 2021.
  2. 2.0 2.1 2.2 BNF (80 ed.). BMJ Group and the Pharmaceutical Press. September 2021 – 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. 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.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. Retrieved 12 April 2019.
  7. Victoria Rees (13 December 2019). "EC approves treatment for severe osteoporosis postmenopausal women". European Pharmaceutical Review. Retrieved 27 February 2020.
  8. 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.
  9. 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.
  10. "Celltech group Interim Report 2002" (PDF). Celltech Group plc.
  11. "New Drug Therapy Approvals 2019". U.S. Food and Drug Administration. 31 December 2019. Retrieved 15 September 2020.

External links

External sites:
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