Last Updated : January 21, 2025
Details
FilesGeneric Name:
omaveloxolone
Project Status:
Active
Therapeutic Area:
Friedreich’s ataxia
Manufacturer:
Biogen Canada Inc.
Call for patient/clinician input open:
Brand Name:
TBC
Project Line:
Reimbursement Review
Project Number:
SR0864-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of Friedreich’s ataxia (FA) in adults and adolescents aged 16
years and older.
Submission Type:
Initial
Fee Schedule:
Schedule E
Indications:
For the treatment of Friedreich's ataxia (FA) in adults and adolescents aged 16 years and older.
- 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 | August 14, 2024 |
|---|---|
| Call for patient/clinician input closed | October 07, 2024 |
| Submission received | October 02, 2024 |
| Submission accepted | October 17, 2024 |
| Review initiated | October 18, 2024 |
| Draft CADTH review report(s) provided to sponsor for comment | January 09, 2025 |
| Deadline for sponsors comments | January 20, 2025 |
| CADTH review report(s) and responses to comments provided to sponsor | February 13, 2025 |
| Expert committee meeting (initial) | February 26, 2025 |
| Draft recommendation issued to sponsor | - |
| Draft recommendation posted for stakeholder feedback | - |
| End of feedback period | - |
Files
Last Updated : January 21, 2025