MedPath

Alirocumab

Generic Name
Alirocumab
Brand Names
Praluent
Drug Type
Biotech
CAS Number
1245916-14-6
Unique Ingredient Identifier
PP0SHH6V16

Overview

Alirocumab is a biopharmaceutical that obtained FDA approval in July 2015 as a second line treatment for high cholesterol in adults whose LDL-cholesterol (LDL-C) is not controlled by the combination of diet and statin treatment. It is a human monoclonal antibody part of the family of the PCSK9 inhibitors which are a novel class of anticholesterol therapeutics. From this family, it was the first agent to receive FDA approval. The FDA approval was contingent on the completion of further clinical trials to better determine efficacy and safety. PCSK9 inhibition facilitates more LDL-C clearance from the blood.

Background

Alirocumab is a biopharmaceutical that obtained FDA approval in July 2015 as a second line treatment for high cholesterol in adults whose LDL-cholesterol (LDL-C) is not controlled by the combination of diet and statin treatment. It is a human monoclonal antibody part of the family of the PCSK9 inhibitors which are a novel class of anticholesterol therapeutics. From this family, it was the first agent to receive FDA approval. The FDA approval was contingent on the completion of further clinical trials to better determine efficacy and safety. PCSK9 inhibition facilitates more LDL-C clearance from the blood.

Indication

Alirocumab is an antibody eliciting proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor activity that is indicated for: (i) use in reducing the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease , and/or (ii) use as an adjunct to diet or use alone or in combination with other lipid-lowering therapies (statins, ezetimibe, for example) for the treatment of adults with primary hyperlipidemia (including heterozygous familial hypercholesterolemia) to reduce low-density lipoprotein cholesterol (LDL-C) levels in the body .

Associated Conditions

  • Heterozygous Familial Hypercholesterolemia (HeFH)
  • Homozygous Familial Hypercholesterolaemia (HoFH)
  • Myocardial Infarction
  • Stroke
  • Unstable Angina Pectoris
  • Primary Hyperlipidemia

FDA Approved Products

Praluent
Manufacturer:Regeneron Pharmaceuticals, Inc.
Route:SUBCUTANEOUS
Strength:75 mg in 1 mL
Approved: 2024/03/08
NDC:61755-020
Praluent
Manufacturer:Sanofi US Corporation
Route:SUBCUTANEOUS
Strength:150 mg in 1 mL
Approved: 2024/03/08
NDC:72733-5902
Praluent
Manufacturer:Sanofi-Aventis U.S. LLC
Route:SUBCUTANEOUS
Strength:75 mg in 1 mL
Approved: 2024/03/08
NDC:0024-5901
Praluent
Manufacturer:Sanofi-Aventis U.S. LLC
Route:SUBCUTANEOUS
Strength:75 mg in 1 mL
Approved: 2024/03/08
NDC:0024-5903
Praluent
Manufacturer:Regeneron Pharmaceuticals, Inc.
Route:SUBCUTANEOUS
Strength:150 mg in 1 mL
Approved: 2024/03/08
NDC:61755-021

Singapore Approved Products

PRALUENT SOLUTION FOR INJECTION IN A PRE-FILLED PEN 75MG/ML
Manufacturer:Sanofi Winthrop Industrie (Pre-filled syringe), Sanofi-Aventis Deutschland GmbH (Assembly of auto-injector)
Form:INJECTION, SOLUTION
Strength:75 mg/ml
Online:Yes
Approved: 2017/04/27
Approval:SIN15228P
PRALUENT SOLUTION FOR INJECTION IN A PRE-FILLED PEN 150 MG/ML
Manufacturer:Sanofi Winthrop Industrie (Pre-filled syringe), Sanofi-Aventis Deutschland GmbH (Assembly of auto-injector)
Form:INJECTION, SOLUTION
Strength:150 mg/ml
Online:Yes
Approved: 2017/04/27
Approval:SIN15229P

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