Moroctocog alfa/Antihemophilic Factor (Recombinant)
Moroctocog alfa was first approved by European Medicine Agency (EMA) on April 13, 1999, then approved by the U.S. Food and Drug Administration (FDA) on March 6, 2000, China Food and Drug Administration (CFDA) on August 16, 2012. It was originally developed by Swedish Orphan Biovitrum, then developed and marketed as ReFacto® and Xyntha® by Wyeth (acquired by Pfizer).
Moroctocog alfa is a recombinant coagulation factor VIII, which replaces the missing clotting factor VIII, thereby enabling a temporary correction of the factor deficiency and correction of the bleeding tendencies. It is indicated for the treatment and prevention of bleeding in patients with haemophilia A.
ReFacto® and Xyntha® are available as injection (lyophilized powder) for intravenous use, containing 250 IU, 500 IU, 1000 IU or 2000 IU of Moroctocog alfa. The dosage and duration of treatment depend on the severity of the factor VIII deficiency, the location and extent of bleeding, and the patient's clinical condition.
Update Date：2016-03-30
- Drug Name：
- Moroctocog alfa/Antihemophilic Factor (Recombinant)
- Research Code：
- Trade Name：
- ReFacto® / Xyntha®
- MOA：
- Blood coagulation pathway activation
- Indication：
- Hemophilia A
- Status：
- Approved
- Company：
- Pfizer (Originator)
- Sales：
-
$533 Million (Y2015);
$631 Million (Y2014);
$602 Million (Y2013);
$584 Million (Y2012);
$506 Million (Y2011); - ATC Code：
- B02BD02
Update Date：2015-09-07
| Approval Date | Approval Type | Trade Name | Indication | Dosage Form | Strength | Company | Review Classification |
|---|---|---|---|---|---|---|---|
| 2008-02-21 | Marketing approval | Xyntha | Hemophilia A | Injection, Lyophilized powder, For solution | 250 IU; 500 IU; 1000 IU; 2000 IU | Wyeth, Pfizer | |
| 2000-03-06 | Marketing approval | ReFacto | Hemophilia A | Injection, Lyophilized powder, For solution | 250 IU; 500 IU; 1000 IU | Wyeth, Pfizer | Orphan |
| Approval Date | Approval Type | Trade Name | Indication | Dosage Form | Strength | Company | Review Classification |
|---|---|---|---|---|---|---|---|
| 1999-04-13 | First approval | ReFacto AF | Hemophilia A | Injection, Powder, For solution | 250 IU; 500 IU; 1000 IU; 2000 IU | Pfizer |
| Approval Date | Approval Type | Trade Name | Indication | Dosage Form | Strength | Company | Review Classification |
|---|---|---|---|---|---|---|---|
| 2012-08-16 | Marketing approval | Xyntha/任捷 | Hemophilia A | Injection, Lyophilized powder, For solution | 250 IU; 500 IU; 1000 IU; 2000 IU | Pfizer |
Update Date：2015-09-07
| Type | Recombinant coagulation factor |
|
| Source | Human | |
| Molecular Formula | ||
| Molecular Weight | ~170000 | |
| CAS No. | 284036-24-4 | |
| Expression System | Mammalian Cell |