Proprotein convertase subtilisin/kexin type 9 (PCSK9)
Clinical data
Trade names
Praluent
AHFS/Drugs.com
Monograph
MedlinePlus
a615035
License data
US DailyMed: Alirocumab
Pregnancy category
AU: B1
Routes of administration
Subcutaneous
ATC code
C10AX14 (WHO)
Legal status
Legal status
AU: S4 (Prescription only)[1]
CA: ℞-only[2]
UK: POM (Prescription only)
US: ℞-only[3][4]
EU: Rx-only[5]
In general: ℞ (Prescription only)
Identifiers
CAS Number
1245916-14-6
DrugBank
DB09302
ChemSpider
none
UNII
PP0SHH6V16
KEGG
D10335
Chemical and physical data
Formula
C6472H9996N1736O2032S42
Molar mass
145983.80 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]
^"Prescription medicines: registration of new chemical entities in Australia, 2016". Therapeutic Goods Administration (TGA). 21 June 2022. Retrieved 10 April 2023.
^"Health Canada New Drug Authorizations: 2016 Highlights". Health Canada. 14 March 2017. Retrieved 7 April 2024.
^Cite error: The named reference Praluent FDA label was invoked but never defined (see the help page).
^ abcCite error: The named reference FDA alirocumab was invoked but never defined (see the help page).
^ ab"Praluent EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 1 April 2021.
^Cite error: The named reference NYT2015-07 was invoked but never defined (see the help page).
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...
Regeneron's drug alirocumab infringed Amgen's patents; Amgen then requested an injunction barring Regeneron and Sanofi from marketing alirocumab, which was...
can lower LDL particle concentrations. The first two PCSK9 inhibitors, alirocumab and evolocumab, were approved as once every two week injections, by the...
metastatic colorectal cancer approved by the FDA in August 2012. Praluent (alirocumab) is indicated as an adjunct to diet and maximally tolerated statin therapy...
(Clopidogrel), for atherothrombosis, marketed by Bristol-Myers Squibb. Praluent (Alirocumab), for heterozygous familial hypercholesterolemia and clinical atherosclerotic...
Injectable antibodies against the protein PCSK9 (evolocumab, bococizumab, alirocumab) can reduce LDL cholesterol and have been shown to reduce mortality. In...
available or studied as injector pens include adalimumab, secukinumab, and alirocumab. CGRP antagonists which are monoclonal antibodies, used for the prevention...
importance of early identification of FH and treatment with statins. Alirocumab and evolocumab, both monoclonal antibodies against PCSK9, are specifically...
Урядовий Кур'єр. Retrieved 26 July 2021. Michael Szarek; et al. (2018). "Alirocumab Reduces Total Nonfatal Cardiovascular and Fatal Events in the ODYSSEY...
million; the voucher cut four months off the regulatory review time for alirocumab and was part of their strategy to beat Amgen to market with the first...
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