Efanesoctocog alfa

Details

Generic Name:
Efanesoctocog alfa
Project Status:
Received
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:
Pending
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
Key Milestones2
Call for patient/clinician input openAugust 07, 2024
Call for patient/clinician input closedSeptember 27, 2024
Submission receivedSeptember 18, 2024
Submission accepted-