Tocilizumab
Tocilizumab was first approved by Pharmaceuticals and Medicals Devices Agency of Japan (PMDA) on September 10, 2007, then approved by European Medicine Agency (EMA) on January 16, 2009, the U.S. Food and Drug Administration (FDA) on January 8, 2010, China Food and Drug Administration (CFDA) on March 26, 2013. It was developed by Chugai (a member of Roche), and marketed as Actemra® and RoActemra® by Roche (Chugai in JP, Genentech in US).
Tocilizumab is an interleukin-6 (IL-6) receptor antagonist, which binds specifically to both soluble and membrane-bound IL-6 receptors (sIL-6R and mIL-6R) and inhibits IL-6 binding. It is indicated for the treatment of patients with rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis and Castleman's disease.
Actemra® and RoActemra® are available as injection (solution) for subcutaneous and intravenous use, containing 80 mg/4 mL, 200 mg/10 mL, 400 mg/20 mL or 162 mg/0.9 mL of Tocilizumab in single-use vial or prefilled syringe. In RA, the recommended dose is 8 mg/kg intravenously or 162 mg subcutaneously once weekly. In JIP, the recommended dose is 10 mg/kg (weighing < 30 kg) or 8 mg/kg (weighing ≥ 30 kg) intravenously every 4 weeks. In SJIA, the recommended dose is 12 mg/kg (weighing < 30 kg) or 8 mg(weighing ≥ 30 kg) intravenously every 2 weeks.
Update Date：2016-03-03
- Drug Name：
- Tocilizumab
- Research Code：
- RO-48775533
- Trade Name：
- Actemra® / RoActemra® / 雅美罗®
- MOA：
- Interleukin-6 receptor antagonist
- Indication：
- Rheumatoid arthritis; Juvenile Rheumatoid Arthritis (JRA); Multicentric Castleman’s Disease (MCD)
- Status：
- Approved
- Company：
- Chugai (Originator) , Genentech,Roche
- Sales：
-
$1491.7 Million (Y2015);
$1345 Million (Y2014);;
$1115 Million (Y2013);;
$895.7 Million (Y2012);;
$694.4 Million (Y2011); - ATC Code：
- L04AC07
Update Date：2015-09-01
| Approval Date | Approval Type | Trade Name | Indication | Dosage Form | Strength | Company | Review Classification |
|---|---|---|---|---|---|---|---|
| 2013-10-21 | New strength | Actemra | Rheumatoid arthritis | Injection, Solution | 162 mg/0.9 mL | Genentech, Roche | Standard |
| 2010-01-08 | Marketing approval | Actemra | Rheumatoid arthritis, Juvenile Rheumatoid Arthritis (JRA) | Injection, Solution | 80 mg/4 mL; 200 mg/10 mL; 400 mg/20 mL | Genentech, Roche | Standard/Orphan |
| Approval Date | Approval Type | Trade Name | Indication | Dosage Form | Strength | Company | Review Classification |
|---|---|---|---|---|---|---|---|
| 2009-01-16 | Marketing approval | RoActemra | Rheumatoid arthritis, Juvenile Rheumatoid Arthritis (JRA) | Injection, Solution, Concentrate | 80 mg/4 mL; 200 mg/10 mL; 400 mg/20 mL | Roche | |
| 2009-01-16 | New strength | RoActemra | Rheumatoid arthritis | Injection, Solution | 162 mg/0.9 mL | Roche |
| Approval Date | Approval Type | Trade Name | Indication | Dosage Form | Strength | Company | Review Classification |
|---|---|---|---|---|---|---|---|
| 2013-03-25 | New strength | Actemra | Rheumatoid arthritis | Injection, Solution | 162 mg/0.9 mL | Chugai | |
| 2008-04-16 | New strength | Actemra | Rheumatoid arthritis, Juvenile Rheumatoid Arthritis (JRA) | Injection, Solution | 80 mg/4 mL; 400 mg/20 mL | Chugai | Orphan |
| 2007-09-10 | Marketing approval | Actemra | Rheumatoid arthritis, Juvenile Rheumatoid Arthritis (JRA) | Injection, Solution | 200 mg/10 mL | Chugai | Orphan |
| Approval Date | Approval Type | Trade Name | Indication | Dosage Form | Strength | Company | Review Classification |
|---|---|---|---|---|---|---|---|
| 2013-03-26 | Marketing approval | Actemra/雅美罗 | Rheumatoid arthritis | Injection, Solution | 80 mg/4 mL; 200 mg/10 mL; 400 mg/20 mL | Chugai, Roche |
Update Date：2015-07-29
| Type | Whole antibody |
|
| Source | Humanized | |
| Molecular Formula | C6428H10008N1720O2018S42 | |
| Molecular Weight | 148000 | |
| CAS No. | 375823-41-9 | |
| Expression System | Mammalian Cell |