Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Recombinant Coagulation Factor IX (BeneFIX)
Recombinant Coagulation Factor IX · 1 trial · 1 indication
Annualized bleed rate (ABR) or number of bleeds per year derived for each participant for each treatment regimen by using the following formula: ABR = number of bleeds / (days on treatment regimen / 365.25)
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | - |
| B | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Recombinant Coagulation Factor IX (BeneFIX) | DRUG | 100 IU/kg once weekly then crossover to 50 IU/kg twice weekly |
Inclusion Criteria: * Documented history of moderately severe or severe hemophilia B (FIX:C less than or equal to 2%) * Male subjects, aged 6 years to 65 years. * Subjects with a minimum of 12 bleeding episodes, 6 of which must be joint bleeds, in the 12 months before screening. Exclusion Criteria...
Top 8 of 9 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| 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 Coagulation Factor IX is used to treat Hemophilia B, a bleeding disorder caused by deficient or defective clotting factor IX. It is given as an exogenous protein to replace the missing factor and support blood clotting. It has been studied in patients with severe Hemophilia B, including on-demand treatment and prophylaxis regimens.
Recombinant Coagulation Factor IX targets F9, also known as coagulation factor IX. It is an exogenous protein that supplies functional factor IX to patients with Hemophilia B, where this clotting factor is absent or defective, thereby restoring the coagulation cascade needed for clot formation.
Recombinant Coagulation Factor IX is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer is the company responsible for the product, which is also known by the brand name BeneFIX.
Recombinant Coagulation Factor IX has been studied in Phase 3 clinical development. It is an investigational product in the context of the trial data available, and it is not described as FDA approved in the supplied information. The Phase 3 trial has been completed.
Recombinant Coagulation Factor IX has been evaluated in the Phase 3 trial NCT00364182, titled Study Comparing On-Demand Treatment With Two Prophylaxis Regimens Of BeneFIX In Patients With Severe Hemophilia B. This completed trial enrolled 50 male patients aged 6 years and older across the United States, Canada, Croatia, Hungary, Italy, Romania, Russia, Serbia, and Spain.
Yes, Recombinant Coagulation Factor IX is also known as BeneFIX. BeneFIX is the brand name for the recombinant coagulation factor IX product developed by Pfizer. The Phase 3 trial NCT00364182 used the name BeneFIX in its title while studying patients with severe Hemophilia B.