daprodustat

Details

Generic Name:
daprodustat
Project Status:
Withdrawn
Therapeutic Area:
Anemia due to chronic kidney disease
Manufacturer:
GlaxoSmithKline Inc.
Brand Name:
TBC
Project Line:
Reimbursement Review
Project Number:
SR0762-000
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis and not on dialysis.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
​Daprodustat tablets are indicated for the treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis and not on dialysis.
  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.
Key Milestones2
Call for patient/clinician input openSeptember 26, 2022
Call for patient/clinician input closedNovember 18, 2022
Clarification:

- Patient input submission received from The Kidney Foundation of Canada

Submission receivedOctober 25, 2022
Submission acceptedNovember 08, 2022
Review initiatedNovember 09, 2022
Draft CADTH review report(s) provided to sponsor for commentFebruary 01, 2023
Deadline for sponsors commentsFebruary 10, 2023
CADTH review report(s) and responses to comments provided to sponsorMarch 09, 2023
Expert committee meeting (initial)March 22, 2023
Clarification:

- CDEC recommendation held pending receipt of NOC and evaluation of the finalized submission requirements.

- Voluntarily withdrawn by the sponsor on 24 Jul 2023.