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Recombinant Factor VIIa BI · 1 trial · 2 indications
No additional hemostatic product required within 12 hours of first dose other than the prescribed dosing regimen.
| Arm | Type | Description |
|---|---|---|
| ≤ 3 doses of 90 µg/kg rFVIIa BI | EXPERIMENTAL | - |
| One dose of 270 µg/kg rFVIIa BI | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Recombinant Factor VIIa BI (rFVIIa BI) | BIOLOGICAL | Administered approximately every 3 hours as an intravenous bolus injection on-demand |
Main Inclusion Criteria: * Participant is male with hemophilia A or B with inhibitors, with a high titer (≥5 Bethesda unit (BU)) or a historical high anamnestic response. * Participant is 12 to 65 years old at the time of screening. * Participant is currently using or has used bypassing agents for ...
Recombinant Factor VIIa BI is an investigational therapy being studied for the on-demand treatment of acute bleeding episodes in patients with hemophilia A and hemophilia B. It is a monoclonal antibody developed by Takeda Pharmaceutical Company Limited and is currently in Phase 3 clinical development.
Recombinant Factor VIIa BI is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting clinical trials to evaluate the drug for the treatment of acute bleeding episodes in patients with hemophilia.
Recombinant Factor VIIa BI is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials to assess its safety and efficacy for treating acute bleeding episodes in hemophilia.
Recombinant Factor VIIa BI has one completed Phase 3 clinical trial, identified as NCT01757405. This trial evaluated the drug for the on-demand treatment of acute bleeding episodes in patients with hemophilia A and hemophilia B, enrolling 40 male participants aged 12 years and older across multiple countries.
Yes, Recombinant Factor VIIa BI is also known as rFVIIa BI. The clinical trial NCT01757405 uses the short name rFVIIa BI to refer to the drug. Both names refer to the same investigational therapy being developed by Takeda for treating acute bleeding episodes in hemophilia.