Alirocumab
Alirocumab was first approved by the U.S. Food and Drug Administration (FDA) on July 24, 2015, then approved by European Medicine Agency (EMA) on September 23, 2015, approved by Pharmaceuticals and Medicals Devices Agency of Japan (PMDA) on July 4, 2016. It was co-developed and co-marketed as Praluent® by Sanofi and Regeneron.
Alirocumab is a proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor, which binds to PCSK9 and inhibits circulating PCSK9 from binding to the low density lipoprotein (LDL) receptor (LDLR), preventing PCSK9-mediated LDLR degradation and permitting LDLR to recycle back to the liver cell surface. It is indicated for the treatment of adult patients with heterozygous familial hypercholesterolemia (HeFH) or patients with clinical atherosclerotic cardiovascular disease such as heart attacks or strokes, who require additional lowering of LDL cholesterol.
Praluent® is available as injection (solution) for subcutaneous use, containing 75 mg or 150 mg of Alirocumab in single-dose prefilled pen or syringe. The recommended dose is 75 mg every 2 weeks.
Update Date：2016-07-05
- Drug Name：
- Alirocumab
- Research Code：
- REGN-727; SAR-236553
- Trade Name：
- Praluent®
- MOA：
- PCSK9 inhibitor
- Indication：
- Hypercholesterolemia
- Status：
- Approved
- Company：
- Sanofi (Originator), Regeneron (Originator)
- Sales：
-
$9.99 Million (Y2015);
- ATC Code：
Update Date：2016-07-05
| Approval Date | Approval Type | Trade Name | Indication | Dosage Form | Strength | Company | Review Classification |
|---|---|---|---|---|---|---|---|
| 2015-07-24 | First approval | Praluent | Hypercholesterolemia | Injection, Solution | 75 mg; 150 mg | Sanofi, Regeneron |
| Approval Date | Approval Type | Trade Name | Indication | Dosage Form | Strength | Company | Review Classification |
|---|---|---|---|---|---|---|---|
| 2015-09-23 | Marketing approval | Praluent | Hypercholesterolemia | Injection, Solution | 75 mg; 150 mg | Sanofi, Regeneron |
| Approval Date | Approval Type | Trade Name | Indication | Dosage Form | Strength | Company | Review Classification |
|---|---|---|---|---|---|---|---|
| 2016-07-04 | Marketing approval | Praluent | Hypercholesterolemia | Injection, Solution | 75 mg; 150 mg | Sanofi |
Update Date：2015-08-17
| Type | Whole antibody |
|
| Source | Human | |
| Molecular Formula | C6472H9996N1736O2032S42 | |
| Molecular Weight | ~146000 | |
| CAS No. | 1245916-14-6 | |
| Expression System | Mammalian Cell |