Alirocumab

Alirocumab
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetProprotein convertase subtilisin/kexin type 9 (PCSK9)
Clinical data
Trade namesPraluent
AHFS/Drugs.comMonograph
MedlinePlusa615035
License data
Pregnancy
category
  • AU: B1
Routes of
administration
Subcutaneous
ATC code
Legal status
Legal status
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
Chemical and physical data
FormulaC6472H9996N1736O2032S42
Molar mass145983.80 g·mol−1

Alirocumab, sold under the brand name Praluent, is a medication used as a second-line treatment for high cholesterol for adults whose cholesterol is not controlled by diet and statin treatment. It is a human monoclonal antibody that belongs to a novel class of anti-cholesterol drugs, known as PCSK9 inhibitors, and it was the first such agent to receive FDA approval. The FDA approval was contingent on the completion of further clinical trials to better determine efficacy and safety.[6]

Common side effects include nasopharyngitis (cold), injection site reactions, and influenza.[4]

It was approved for medical use in the United States[4] and in the European Union in 2015.[5]

  1. ^ "Prescription medicines: registration of new chemical entities in Australia, 2016". Therapeutic Goods Administration (TGA). 21 June 2022. Retrieved 10 April 2023.
  2. ^ "Health Canada New Drug Authorizations: 2016 Highlights". Health Canada. 14 March 2017. Retrieved 7 April 2024.
  3. ^ Cite error: The named reference Praluent FDA label was invoked but never defined (see the help page).
  4. ^ a b c Cite error: The named reference FDA alirocumab was invoked but never defined (see the help page).
  5. ^ a b "Praluent EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 1 April 2021.
  6. ^ Cite error: The named reference NYT2015-07 was invoked but never defined (see the help page).