Last Updated : July 24, 2023
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Withdrawn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.
- 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.
| Call for patient/clinician input open | September 26, 2022 |
|---|---|
| Call for patient/clinician input closed | November 18, 2022 |
| Clarification: - Patient input submission received from The Kidney Foundation of Canada | |
| Submission received | October 25, 2022 |
| Submission accepted | November 08, 2022 |
| Review initiated | November 09, 2022 |
| Draft CADTH review report(s) provided to sponsor for comment | February 01, 2023 |
| Deadline for sponsors comments | February 10, 2023 |
| CADTH review report(s) and responses to comments provided to sponsor | March 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 - Voluntarily withdrawn by the sponsor on 24 Jul 2023. | |
Last Updated : July 24, 2023