Evolocumab

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Evolocumab
Monoclonal antibody
Type Whole antibody
Source Human
Target PCSK9
Clinical data
Trade names Repatha
Legal status
  • ℞ (Prescription only)
Routes of
administration		 Subcutaneous injection
Identifiers
CAS Number 1256937-27-5
ATC code C10AX13 (WHO)
UNII LKC0U3A8NJ YesY
Synonyms AMG-145[1]
Chemical data
Formula C6242H9648N1668O1996S56
Molecular mass 141.8 kg/mol

Evolocumab[2] (INN, trade name Repatha) is a monoclonal antibody designed for the treatment of hyperlipidemia by Amgen.[3] Evolocumab is a fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9).

PCSK9 is a protein that targets LDL receptors for degradation and thereby reduces the liver's ability to remove LDL-C, or "bad" cholesterol, from the blood.[4]

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 the liver to remove LDL-C from the blood.

Approval status

Amgen submitted Biologics License Application (BLA) for evolocumab to the FDA in August 2014.[5] 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.[6] European Commission approved it in July 2015.[7] Evolocumab received approval from Health Canada on September 10, 2015.[8] Amgen reported approval by Health Canada in a press release on September 15, 2015. [9]

References

  1. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  2. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  3. ↑ Statement On A Nonproprietary Name Adopted By The USAN Council - Evolocumab
  4. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  5. ↑ Amgen Submits Biologics License Application For Novel Investigational LDL Cholesterol-Lowering Medication Evolocumab To The FDA
  6. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  7. ↑ 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
  8. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  9. ↑ Lua error in package.lua at line 80: module 'strict' not found.

External links

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