Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as moroctocog alfa (AF-CC), Refacto AF
moroctocog alfa · 6 trials · 1 indication
ABR for each participant was calculated as the number of bleeds requiring administration of moroctocog alfa (AF-CC) divided by the total therapy duration (in days), then multiplied by 365.25 (days in a year).
Efficacy at the end of surgery as determined by the investigator and/or the surgeon using the 4 point ordinal scale (Excellent, Good, Moderate or None). Excellent: Achieved hemostatic comparable to non-hemophilic patients. Good: Prolonged time to hemostasis (with somewhat increased bleeding compared to non-hemophilic patients.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | On-Demand therapy for 6 months, followed by Routine Prophylaxis treatment for 1 year. |
| 2 | EXPERIMENTAL | Routine Prophylaxis Crossover |
| A | EXPERIMENTAL | - |
| B | EXPERIMENTAL | - |
| Sequence 1 | EXPERIMENTAL | Subjects randomized to receive Treatment A during Period 1, then Treatment B during Period 2. |
| Sequence 2 | EXPERIMENTAL | Subjects randomized to receive Treatment B during Period 1, then Treatment B during Period 2. |
| Name | Type | Description |
|---|---|---|
| Moroctocog alfa (AF-CC) | BIOLOGICAL | On-demand therapy for 6 months, followed by routine prophylaxis 25 IU/kg, administered every other day for 1 year. |
| ReFacto AF | BIOLOGICAL | - |
| B-Domain deleted Recombinant Factor VIII | GENETIC | - |
| BDDrFVIII | GENETIC | - |
Inclusion Criteria: * Male subjects, aged less than 6 years, with moderately severe to severe hemophilia A. * A negative FVIII inhibitor titer at screening, and a medical history negative for a past FVIII inhibitor. * At least 20 exposure days to any FVIII replacement product. * Adequate hepatic an...
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 |
Moroctocog alfa is used to treat hemophilia A, a bleeding disorder caused by deficient or defective factor VIII. It is a recombinant factor VIII replacement therapy developed by Pfizer for patients with hemophilia A, including use as prophylaxis to reduce bleeding episodes.
Moroctocog alfa targets factor VIII, also known as F8. It is an exogenous protein that supplies functional factor VIII to replace the missing or defective clotting protein in hemophilia A patients, thereby supporting normal blood coagulation.
Moroctocog alfa is developed and manufactured by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer conducted the clinical development program for this recombinant factor VIII product.
Moroctocog alfa has been studied in Phase 3 clinical development for hemophilia A. It is an investigational recombinant factor VIII therapy, and both of its registered trials are completed with no active trials currently listed.
Moroctocog alfa has been evaluated in two completed trials. NCT00543439 was a Phase 3 study of prophylaxis treatment, efficacy, safety, and pharmacokinetics in hemophilia A with 66 patients. NCT01579903 was a Phase 1 relative bioavailability study of two formulations with 16 patients.
Yes, moroctocog alfa (AF-CC) is an alternative name for moroctocog alfa. The AF-CC designation refers to the albumin-free cell culture formulation of this recombinant factor VIII product, and both names refer to the same Pfizer hemophilia A therapy.