Last Updated : November 12, 2024
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 | 07-Aug-24 |
|---|---|
| Call for patient/clinician input closed | 27-Sep-24 |
| Submission received | 18-Sep-24 |
| Submission accepted | 03-Oct-24 |
| Review initiated | 04-Oct-24 |
| Draft CADTH review report(s) provided to sponsor for comment | 23-Dec-24 |
| Deadline for sponsors comments | 09-Jan-25 |
| CADTH review report(s) and responses to comments provided to sponsor | 13-Feb-25 |
| Expert committee meeting (initial) | 26-Feb-25 |
Files
Last Updated : November 12, 2024