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Also known as Recombinant Factor VIIa BI (rFVIIa BI)
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 ...
Top 8 of 9 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
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| Novo Nordisk A/S Sponsored ADR Class B | NVO | 15 | PHASE3 | Concizumab, Mim8, Denecimig, NNC0442-0344 A, turoctocog alfa pegol |
| Sanofi SA Sponsored ADR | SNY | 5 | PHASE3 | Fitusiran, efanesoctocog alfa |
| Pfizer Inc. | PFE | 8 | PHASE3 | Fidanacogene elaparvovec, Marstacimab |
| BioMarin Pharmaceutical Inc. | BMRN | 2 | PHASE3 | Valoctocogene roxaparvovec |
| Hoffmann-La Roche | RHHBY | 8 | PHASE3 | Emicizumab, NXT007, SPK-8011QQ, SPK-8011, SPK-8016 |
| Regeneron Pharmaceuticals, Inc. | REGN | 2 | PHASE1 | REGV131, LNP1265 |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 2 | PHASE1 | AskBio009 |
| Bayer | BAYRY | 6 | - | Damoctocog-alfa-pegol |
Recombinant Factor VIIa BI is an investigational biologic therapy developed by Takeda Pharmaceutical Company Limited for the treatment of bleeding episodes in patients with hemophilia. It is a recombinant form of activated factor VII, a protein involved in the blood clotting cascade, and is given on an on-demand regimen to control acute bleeding.
Recombinant Factor VIIa BI is being studied for the treatment of acute bleeding episodes in patients with hemophilia A and hemophilia B. It is administered on an on-demand basis, meaning it is given to stop bleeding when it occurs rather than as routine prophylaxis.
Recombinant Factor VIIa BI targets F9, also known as factor IX, a clotting factor that is deficient or defective in hemophilia B. It is an exogenous protein designed to support the coagulation cascade and promote clot formation during acute bleeding episodes in patients with hemophilia.
Recombinant Factor VIIa BI is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor responsible for the clinical development of the program in hemophilia.
Recombinant Factor VIIa BI is in Phase 3 clinical development. It is an investigational therapy and has not been established as approved for commercial use. The Phase 3 trial evaluating it has been completed.
Recombinant Factor VIIa BI has been evaluated in the Phase 3 trial NCT01757405, titled Recombinant Factor VIIa BI (rFVIIa BI) Treatment of Acute Bleeding Episodes Per an On-demand Regimen. That trial enrolled 40 male participants aged 12 years and older across the United States, Japan, Poland, Romania, Russia, Serbia, Spain, Taiwan, and Ukraine, and it is completed.
Yes, Recombinant Factor VIIa BI is also known as rFVIIa BI. The abbreviated form rFVIIa BI refers to the same investigational Takeda product, so searches for either name point to the same hemophilia program.