Evolocumab

Source: Wikipedia, the free encyclopedia.

Evolocumab
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetPCSK9
Clinical data
PronunciationEE-voh-lock-yoo-mab
Trade namesRepatha
Other namesAMG-145[1]
AHFS/Drugs.comMonograph
License data
Pregnancy
category
  • AU: B1
Subcutaneous
ATC code
Legal status
Legal status
Identifiers
CAS Number
ChemSpider
  • none
UNII
KEGG
Chemical and physical data
FormulaC6242H9648N1668O1996S56
Molar mass141790.89 g·mol−1

Evolocumab,[5] sold under the brand name Repatha, is a monoclonal antibody that is an immunotherapy medication for the treatment of hyperlipidemia.

Evolocumab is a fully human monoclonal antibody that inhibits

LDL-C, often colloquially referred to as "bad" cholesterol, from the blood.[6][7]

Mechanism

Evolocumab is designed to bind to PCSK9 and inhibit PCSK9 from binding to LDL receptors on the liver surface. In the absence of PCSK9, there are more LDL receptors on the surface of liver cells to remove LDL-C from the blood.[8]

Adverse effects

Injection site reactions such as redness and pain are common and are reported in approximately 2.1–4.3% of cases.[9][10] Concerns about mortality rate underreporting in the FOURIER study have attracted some controversy in the media.[11]

History

Amgen submitted a

FDA in August 2014.[12] The FDA approved evolocumab injection on 27 August 2015, for some patients who are unable to get their LDL cholesterol under control with current treatment options.[13] The European Commission approved it in July 2015.[14] Evolocumab received approval from Health Canada on September 10, 2015.[15] Amgen reported approval by Health Canada in a press release on September 15, 2015.[16]

Results of the FOURIER trial were published in March 2017.[17]

KSR v. Teleflex
.

Issued Amgen's patents have a so-called “functional genus claim,” which defines an antibody by its epitope, the specific target against which it binds. Although, Amgen did discover the target

pharmaceuticals, since the purpose of the patent system is to provide an incentive for earlier disclosure in the gambling game from-discovery-to-market, that does not necessarily reward every participant according to their contribution, but encourages discovers and inventors to play the gambling game nevertheless.[21]

Society and culture

Economics

In 2015 it cost about US$14,100 per year. One article calculated this to be about $400,000 to $500,000 per quality-adjusted life year (QALY), which did not meet "generally accepted" cost-benefit thresholds. The authors calculated that an annual cost of $4,500 would meet an acceptable $100,000 per QALY standard.[22] On October 26, 2018, the maker of the drug, Amgen, announced a 60% cut in price and the drug at that date cost $5,850 per year.[23]

References

  1. S2CID 34214247
    .
  2. ^ "Prescription medicines: registration of new chemical entities in Australia, 2015". Therapeutic Goods Administration (TGA). 21 June 2022. Retrieved 10 April 2023.
  3. ^ "Health Canada New Drug Authorizations: 2015 Highlights". Health Canada. 4 May 2016. Retrieved 7 April 2024.
  4. ^ "Repatha- evolocumab injection, solution Repatha- evolocumab kit". DailyMed. U.S. National Library of Medicine. 6 May 2020. Retrieved 20 October 2020.
  5. hdl:10665/331167
    .
  6. S2CID 248918656
    .
  7. S2CID 2201087
    .
  8. ^ "PCSK9 инхибитори – нов клас медикаменти за лечение на дислипидемия" [PCSK9 inhibitors – a new class of drugs for the treatment of dyslipidemia]. Списание МД [MD Journal] (in Bulgarian). November 2016. Retrieved 28 October 2018 – via spisaniemd.bg.
  9. PMID 32821708
    .
  10. S2CID 1972937
    .
  11. ^ "Altmetric – Restoring mortality data in the FOURIER cardiovascular outcomes trial of evolocumab in patients with cardiovascular disease: a reanalysis based on regulatory data". bmj.altmetric.com.
  12. ^ "Amgen Submits Biologics License Application For Novel Investigational LDL Cholesterol-Lowering Medication Evolocumab To The FDA". Amgen. 28 August 2014.
  13. ^ "FDA approves Repatha to treat certain patients with high cholesterol". FDA News Release. U.S. Food and Drug Administration. U.S. Food and Drug Administration. 27 August 2015. Retrieved 30 August 2015.
  14. ^ "European Commission Approves Amgen's New Cholesterol-Lowering Medication Repatha™ (evolocumab), The First PCSK9 Inhibitor To Be Approved In The World, For Treatment Of High Cholesterol". Amgen. 21 July 2015. Archived from the original on 22 July 2015. Retrieved 11 January 2020.
  15. ^ "Regulatory Decision Summary (SBD): REPATHA - 2015 - Health Canada". www.hc-sc.gc.ca. Archived from the original on 7 October 2015. Retrieved 6 October 2015.
  16. ^ "Amgen - Media - In The News". www.amgen.ca. Archived from the original on 4 March 2016. Retrieved 17 September 2015.
  17. S2CID 1972937
    .
  18. ^ Feeley J, Bloomfield D, Decker S (5 January 2017). "Amgen Wins Ban on Sanofi's Praluent Cholesterol Drug Sales". Bloomberg News.
  19. ^ a b "Amgen Inc. V. Sanofi". SCOTUSblog.
  20. S2CID 254435116
    .
  21. S2CID 257765649
    .
  22. PMID 27533159
    .
  23. ^ Goldman D. "The bigger message behind Amgen's decision to slash cost of its Repatha cholesterol drug". MarketWatch. Retrieved 28 October 2018.
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