Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Antihemophilic Factor- Plasma/Albumin Free Method · 3 trials · 1 indication
Inhibitory antibodies to FVIII were measured using the Nijmegen modification of the Bethesda assay. Incidence of an FVIII inhibitory antibody was defined as an inhibitor level ≥0.6 Bethesda units \[BU\].
Comparisons between prophylactic and on-demand treatment were based on ABR estimates from a negative binomial regression model, taking into account the treatment regimen, target joints and age at screening, and duration of the observation period for efficacy.
| Arm | Type | Description |
|---|---|---|
| <6 years old | EXPERIMENTAL | - |
| ≥6 to <12 years | EXPERIMENTAL | - |
| Prophylaxis | EXPERIMENTAL | - |
| On-demand | EXPERIMENTAL | - |
| Cohort 1 | EXPERIMENTAL | Low dose of ADVATE followed by low dose of BAX 855 |
| Cohort 2 | EXPERIMENTAL | High dose of ADVATE followed by high dose of BAX 855 |
| Name | Type | Description |
|---|---|---|
| Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method | BIOLOGICAL | Pharmacokinetic (PK) analysis of ADVATE |
| PEGylated Recombinant Factor VIII | BIOLOGICAL | Pharmacokinetic (PK) analysis of BAX 855 |
Inclusion Criteria: * Severe hemophilia A (Factor VIII (FVIII) \<1%) determined by central laboratory. * \<12 years old at the time of screening. * Participants aged ≥6 to \<12 years of age have been previously treated with plasma-derived and/or recombinant Factor VIII (rFVIII) concentrate(s) for a...
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 |
Antihemophilic Factor- Plasma/Albumin Free Method is used to treat Hemophilia A, a bleeding disorder caused by missing or defective factor VIII. It is a recombinant factor VIII therapy developed by Takeda Pharmaceutical Company Limited and is in Phase 3 clinical development.
Antihemophilic Factor- Plasma/Albumin Free Method targets factor VIII (F8), the clotting protein that is deficient or dysfunctional in Hemophilia A. By supplying exogenous factor VIII, the therapy aims to restore the coagulation cascade and improve clot formation in patients with this bleeding disorder.
Antihemophilic Factor- Plasma/Albumin Free Method is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor of the clinical development program for this recombinant factor VIII therapy.
Antihemophilic Factor- Plasma/Albumin Free Method is in Phase 3 clinical development. It is an investigational therapy for Hemophilia A and has not been approved by the FDA. The program includes completed Phase 1, Phase 2, and Phase 3 trials.
Antihemophilic Factor- Plasma/Albumin Free Method has been studied in three completed clinical trials: NCT02210091, a Phase 3 pediatric study; NCT01736475, a Phase 2 study known as PROLONG-ATE; and NCT01599819, a Phase 1 dose-escalation safety study. All trials enrolled patients with Hemophilia A.