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Also known as Antihemophilic Factor (Recombinant), Antihemophilic Factor
Antihemophilic factor, recombinant, manufactured protein-free · 4 trials · 1 indication
Terminal phase half-life of rAHF-PFM was to be determined using the biphasic linear regression model.
Area under the factor VIII (FVIII) plasma concentration versus time curve (AUC) from 0 to 48 hours estimated using the linear trapezoidal method
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | ADVATE reconstituted in 2 mL sterile water for infusion |
| 2 | ACTIVE_COMPARATOR | ADVATE reconstituted in 5 mL sterile water for infusion |
| Name | Type | Description |
|---|---|---|
| Antihemophilic factor, recombinant, manufactured protein-free | DRUG | - |
| Antihemophilic factor, recombinant, manufactured protein-free (rAHF-PFM). (Antihemophilic factor is also known as Factor VIII) | BIOLOGICAL | Subjects are randomized to receive an infusion of rAHF-PFM reconstituted in 2 mL sterile water for infusion (SWFI) followed (after a wash-out period) by rAHF-PFM reconstituted in 5 mL SWFI or in 5 mL then 2 mL SWFI(cross-over design). Each subject will receive 2 infusions. |
Inclusion Criteria: * Subject is less than 6 years of age * Severe or moderately-severe hemophilia A as defined by a baseline factor VIII level \<= 2%, documented at screening or on the basis of historical data (e.g., at hemophilia diagnosis) * Documented medical history of at least 50 exposure day...
Top 6 of 7 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novo Nordisk A/S Sponsored ADR Class B | NVO | 14 | PHASE3 | Concizumab, Mim8, NNC0442-0344 A, turoctocog alfa pegol, nonacog beta pegol |
| Sanofi SA Sponsored ADR | SNY | 5 | PHASE3 | Fitusiran, efanesoctocog alfa |
| Pfizer Inc. | PFE | 7 | PHASE3 | Fidanacogene elaparvovec, Marstacimab |
| BioMarin Pharmaceutical Inc. | BMRN | 2 | PHASE3 | Valoctocogene roxaparvovec |
| Regeneron Pharmaceuticals, Inc. | REGN | 2 | PHASE1 | REGV131, LNP1265 |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 2 | PHASE1 | AskBio009 |
It is used to treat Hemophilia A, a bleeding disorder caused by deficient or missing clotting factor VIII. The product is a recombinant, protein-free form of factor VIII developed by Takeda Pharmaceutical Company Limited. It is studied for use in patients with Hemophilia A, including those undergoing surgery and pediatric patients.
It targets F8, also known as factor VIII, an exogenous protein. By supplying functional factor VIII, it replaces the clotting factor that is missing or deficient in people with Hemophilia A, supporting normal blood coagulation. The target class is an exogenous protein rather than a small molecule or antibody target.
Takeda Pharmaceutical Company Limited develops antihemophilic factor, recombinant, manufactured protein-free. Takeda trades under the ticker TAK. The company is the sponsor behind the clinical studies of this recombinant factor VIII product in Hemophilia A.
It is in Phase 2 clinical development. Four trials have been completed, with no active trials currently listed. The studies enrolled a total of 243 participants and included randomized, active-controlled designs. It is an investigational product and is not described as approved.
Completed trials include NCT00952822, a Phase 1 pharmacokinetic study with 52 participants; NCT00157105, a Phase 2 surgical study with 59 participants; NCT00157053, a Phase 2 continuation study with 82 participants; and NCT00157040, a Phase 2 pediatric study with 50 participants. All four studies were in Hemophilia A.
Yes. Antihemophilic factor, recombinant, manufactured protein-free is also known as rAHF-PFM. Antihemophilic factor is also known as Factor VIII, so searches for Antihemophilic Factor (Recombinant) refer to the same product. These names describe the same recombinant, protein-free factor VIII therapy.