PARAMETER

DATA

Manufacturer

Sanofi-Aventis U.S. Inc.

Indication

PRALUENT is a PCSK9 (Proprotein Convertase Subtilisin Kexin Type 9) inhibitor antibody indicated as adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who require additional lowering of LDL-cholesterol (LDL-C)

Cell Substrate

Chinese Hamster Ovary (CHO) cell suspension culture

Manufacturing platform

The manufacture of alirocumab active substance corresponds to a conventional monoclonal antibody production process (fermentation, recovery, purification including viral inactivation/filtration). Upstream processing begins with thawing of a frozen vial of the working cell bank (WCB), and resuspending the cells into a shake flask. The cell culture is expanded in a series of cell bags and bioreactors of increasing volume until reaching sufficient density for inoculation into the production bioreactor. Downstream processing consists of several chromatography steps (rProtein A affinity chromatography, anion exchange chromatography, hydrophobic interaction chromatography) as well as viral inactivation and filtration steps to purify and clear potential adventitious viral agents from the product. Concentration and diafiltration of alirocumab creates pre-formulated active substance. The material is then compounded to 150 mg/mL resulting in alirocumab FDS. The FDS is dispensed into containers and stored frozen.

Dose in vial/final container

• 75 mg/mL or 150 mg/mL solution in a single-dose pre-filled pen
• 75 mg/mL or 150 mg/mL solution in a single-dose pre-filled syringe

Dose to patient

• 75 mg administered subcutaneously once every 2 weeks
• 300 mg once every 4 weeks

NCT

TRIAL PHASE

NO OF PATIENTS ENROLLED

STUDY TITLE

COUNTRIES

Phase 3 trials

NCT01623115

3

486

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   

United States, Czech Republic, Austria, Canada, Denmark, France, Israel, Spain, Norway, Netherlands, Sweden, South Africa, Russian Federation, United Kingdom

NCT01709500

3

249

Study of Alirocumab (REGN727/SAR236553) in Patients with heFH (Heterozygous Familial Hypercholesterolemia) who are not Adequately Controlled with Their LMT (Lipid-Modifying Therapy)        

Czech Republic, Netherlands, Norway, United Kingdom

NCT01617655

3

107

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

United States, Canada, Netherlands, Russian Federation, South Africa

NCT01507831

3

2341

Long-term Safety and Tolerability of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in High Cardiovascular Risk Patients with Hypercholesterolemia (ODYSSEY Long Term)           

United States, Chile, Argentina, Belgium, Bulgaria, Canada, Colombia, Czech Republic, Denmark, Finland, France, Italy, Germany, Hungary, Israel, Mexico, Spain,  Netherlands, Norway, Poland, Portugal, Romania, Russian Federation, South Africa, Sweden, Ukraine, United Kingdom

NCT01644175

3

316

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)

United States

NCT01644188

3

720

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

United States, Canada, Israel, Denmark, France, Hungary, Korea, Republic of, Russian Federation, South Africa, Ukraine

NCT01730040

3

355

Study of the Efficacy and Safety of Alirocumab (REGN727/SAR236553) in Combination With Other Lipid-modifying Treatment (LMT) (ODYSSEY OPTIONS I)

United States, Australia, Italy, Canada, France, Germany, Mexico, Spain, United Kingdom

NCT01730053

3

305

Study of Alirocumab (REGN727/SAR236553) added-on to Rosuvastatin Versus Other Lipid Modifying Treatments (LMT) (ODYSSEY OPTIONS II)

United States, Australia, Italy, Canada, France, Germany, Mexico, Spain, United Kingdom

NCT01709513

3

314

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)

United States, Austria, Italy, Canada, France, Norway,  Israel, United Kingdom

NCT01644474

3

103

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

United States, Belgium, Finland, Netherlands