Last Updated : March 31, 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:
Altuviiio
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 review report(s) provided to sponsor for comment | 23-Dec-24 |
| Deadline for sponsors comments | 09-Jan-25 |
| review report(s) and responses to comments provided to sponsor | 13-Feb-25 |
| Expert committee meeting (initial) | 26-Feb-25 |
| Draft recommendation issued to sponsor | - |
| Clarification: - CPEC recommendation held pending receipt of NOC and evaluation of the finalized submission requirements. | |
| Draft recommendation posted for stakeholder feedback | - |
| End of feedback period | - |
Files
Last Updated : March 31, 2025