Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ReFacto AF · 4 trials · 1 indication
Efficacy at the end of surgery as determined by the investigator and/or the surgeon using the 4 point ordinal scale (Excellent, Good, Moderate or None). Excellent: Achieved hemostatic comparable to non-hemophilic patients. Good: Prolonged time to hemostasis (with somewhat increased bleeding compared to non-hemophilic patients.
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | - |
| B | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| ReFacto AF | BIOLOGICAL | - |
| B-Domain deleted Recombinant Factor VIII | GENETIC | - |
| BDDrFVIII | GENETIC | - |
* Male, at least 12 years old, with severe hemophilia A undergoing major elective major surgery requiring FVIII replacement for at least 6 days. Negative FVIII inhibitor test at screening and no past history of inhibitor. * Previously treated with at least 150 exposure days to any Factor VIII produc...
ReFacto AF is used for the treatment of Hemophilia A, a bleeding disorder. It is developed by Pfizer, Inc. (NYSE: PFE) and is currently in Phase 3 clinical development. ReFacto AF is a small molecule therapy being studied for its efficacy and safety in patients with this condition.
ReFacto AF is a B-domain deleted recombinant factor VIII (BDDrFVIII) product. It works by replacing the missing or defective clotting factor VIII in patients with Hemophilia A, helping to restore normal blood clotting. This mechanism is based on the drug's composition as a recombinant factor VIII concentrate.
ReFacto AF is developed by Pfizer, Inc., a multinational pharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. Pfizer is responsible for the clinical development and manufacturing of this investigational therapy for Hemophilia A.
ReFacto AF is in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The Phase 3 trials are designed to evaluate its safety and efficacy in patients with Hemophilia A, including studies on bioequivalence and use during surgery.
ReFacto AF has been studied in four completed Phase 3 clinical trials, including NCT00037544, NCT00038935, NCT00141843, and NCT00243659. These trials evaluated the drug in patients with Hemophilia A, including a bioequivalence study comparing ReFacto AF with Advate and a study in patients undergoing elective major surgery.
Yes, ReFacto AF is also known as B-domain deleted recombinant factor VIII (BDDrFVIII). Clinical trial titles refer to it as BDDrFVIII, and it is the same drug product. This naming reflects the molecular structure of the therapy, which lacks the B-domain of the factor VIII protein.