CDA | Evidence Driven
CDA | Evidence Driven

omaveloxolone

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Generic 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.
  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 open14-Aug-24
Call for patient/clinician input closed07-Oct-24
Submission received02-Oct-24
Submission accepted17-Oct-24
Review initiated18-Oct-24
Draft CADTH review report(s) provided to sponsor for comment09-Jan-25
Deadline for sponsors comments20-Jan-25
CADTH review report(s) and responses to comments provided to sponsor13-Feb-25
Expert committee meeting (initial)26-Feb-25
Draft recommendation issued to sponsor-
Draft recommendation posted for stakeholder feedback-
End of feedback period-

Files

Patient and Clinician Group input View PDF
Last Updated : October 22, 2024