Alirocumab

Generic Name: Alirocumab

Brand Names: Praluent

Drug Type: Biotech

CAS Number: 1245916-14-6

Unique Ingredient Identifier: PP0SHH6V16

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

Clinical Trials

Study of Alirocumab (REGN727/SAR236553) in Patients With Primary Hypercholesterolemia and Moderate, High, or Very High Cardiovascular (CV) Risk, Who Are Intolerant to Statins (ODYSSEY ALTERNATIVE)

Phase 3

Completed

Conditions: Hypercholesterolemia

Interventions: Drug: Atorvastatin
Drug: Ezetimibe
Drug: Alirocumab
Drug: Placebo

First Posted Date: 2012-10-18

Last Posted Date: 2020-06-23

Lead Sponsor: Regeneron Pharmaceuticals

Target Recruit Count: 314

Registration Number: NCT01709513

Pharmacokinetic and Tolerability of Alirocumab SAR236553 (REGN727) in Patients With Hepatic Impairment and in Healthy Subjects

Phase 1

Completed

Conditions: Hypercholesterolemia

Interventions: Drug: alirocumab SAR236553 (REGN727)

First Posted Date: 2012-08-22

Last Posted Date: 2013-06-28

Lead Sponsor: Sanofi

Target Recruit Count: 25

Registration Number: NCT01670734

Locations: 🇫🇷
Investigational Site Number 250001, Rennes, France
🇲🇩
Investigational Site Number 498001, Chisinau, Moldova, Republic of

ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab

Phase 3

Completed

Conditions: Atherosclerotic Cardiovascular Disease

Interventions: Drug: Placebo
Drug: Alirocumab
Drug: LMT

First Posted Date: 2012-08-13

Last Posted Date: 2019-03-18

Lead Sponsor: Sanofi

Target Recruit Count: 18924

Registration Number: NCT01663402

Locations: 🇺🇸
Investigational Site Number 840075, Atlanta, Georgia, United States
🇺🇸
Investigational Site Number 840231, Philadelphia, Pennsylvania, United States
🇺🇸
Investigational Site Number 840339, Philadelphia, Pennsylvania, United States

and more 1385 locations

Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe in Patients With Hypercholesterolemia

Phase 3

Completed

Conditions: Hypercholesterolemia

Interventions: Drug: Ezetimibe
Drug: Alirocumab
Drug: Placebo (for Alirocumab)
Drug: Placebo (for Ezetimibe)

First Posted Date: 2012-07-19

Last Posted Date: 2015-11-06

Lead Sponsor: Sanofi

Target Recruit Count: 103

Registration Number: NCT01644474

Locations: 🇺🇸
Investigational Site Number 840603, Overland Park, Kansas, United States
🇺🇸
Investigational Site Number 840601, Cincinnati, Ohio, United States
🇳🇱
Investigational Site Number 528602, Groningen, Netherlands

and more 5 locations

Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe on Top of Statin in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY COMBO II)

Phase 3

Completed

Conditions: Hypercholesterolemia

Interventions: Drug: Placebo (for alirocumab)
Drug: Alirocumab
Drug: Placebo (for ezetimibe)
Drug: Ezetimibe
Drug: Lipid Modifying Therapy (LMT)

First Posted Date: 2012-07-18

Last Posted Date: 2016-08-04

Lead Sponsor: Sanofi

Target Recruit Count: 720

Registration Number: NCT01644188

Locations: 🇺🇸
Investigational Site Number 840979, Los Angeles, California, United States
🇺🇸
Investigational Site Number 840966, Fall River, Massachusetts, United States
🇺🇸
Investigational Site Number 840946, Butte, Montana, United States

and more 123 locations

Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With High Cardiovascular Risk and Hypercholesterolemia (ODYSSEY COMBO I)

Phase 3

Completed

Conditions: Hypercholesterolemia

Interventions: Drug: Placebo (for alirocumab)
Drug: Alirocumab
Drug: Lipid-Modifying Therapy (LMT)

First Posted Date: 2012-07-18

Last Posted Date: 2015-11-06

Lead Sponsor: Sanofi

Target Recruit Count: 316

Registration Number: NCT01644175

Locations: 🇺🇸
Investigational Site Number 840827, Mt. Pleasant, South Carolina, United States
🇺🇸
Investigational Site Number 840832, Southfield, Michigan, United States
🇺🇸
Investigational Site Number 840891, Mobile, Alabama, United States

and more 73 locations

Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy

Phase 3

Completed

Conditions: Hypercholesterolemia

Interventions: Drug: Placebo (for alirocumab)
Drug: Alirocumab
Drug: Lipid Modifying Therapy (LMT)

First Posted Date: 2012-06-19

Last Posted Date: 2016-02-08

Lead Sponsor: Sanofi

Target Recruit Count: 486

Registration Number: NCT01623115

Locations: 🇺🇸
Investigational Site Number 840421, Mission Viejo, California, United States
🇺🇸
Investigational Site Number 840452, Washington, District of Columbia, United States
🇺🇸
Investigational Site Number 840425, Auburn, Maine, United States

and more 88 locations

Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia (ODYSSEY HIGH FH)

Phase 3

Completed

Conditions: Hypercholesterolaemia

Interventions: Drug: Placebo (for alirocumab)
Drug: Alirocumab
Drug: Lipid Modifying Therapy (LMT)

First Posted Date: 2012-06-12

Last Posted Date: 2016-10-04

Lead Sponsor: Sanofi

Target Recruit Count: 107

Registration Number: NCT01617655

Locations: 🇺🇸
Investigational Site Number 840742, Bell Gardens, California, United States
🇺🇸
Investigational Site Number 840743, Northridge, California, United States
🇺🇸
Investigational Site Number 840710, Ponte Vedra, Florida, United States

and more 32 locations