Last Updated : February 26, 2025
Details
FilesGeneric Name:
efanesoctocog alfa
Project Status:
Active
Therapeutic Area:
congenital factor VIII deficiency
Manufacturer:
Sanofi-aventis Canada Inc.
Call for patient/clinician input open:
Brand Name:
TBC
Project Line:
Reimbursement Review
Project Number:
ST0840-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Efanesoctocog alfa is a long-acting recombinant antihemophilic factor (coagulation FVIII) with high sustained FVIII activity indicated in adults and children with hemophilia A (congenital FVIII deficiency) for: • Routine prophylaxis to reduce the frequency of bleeding episodes • On-demand treatment and control of bleeding episodes • Perioperative management of bleeding
| Call for patient/clinician input open | August 07, 2024 |
|---|---|
| Call for patient/clinician input closed | September 27, 2024 |
| Submission received | September 18, 2024 |
| Submission accepted | October 03, 2024 |
| Review initiated | October 04, 2024 |
| Draft CADTH review report(s) provided to sponsor for comment | December 23, 2024 |
| Deadline for sponsors comments | January 09, 2025 |
| CADTH review report(s) and responses to comments provided to sponsor | February 13, 2025 |
| Expert committee meeting (initial) | February 26, 2025 |
| Draft recommendation issued to sponsor | - |
| Draft recommendation posted for stakeholder feedback | - |
| End of feedback period | - |
Files
Last Updated : February 26, 2025