Canada’s Drug Agency | Drugs, Health Technologies and Systems.

odevixibat

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Generic Name:
odevixibat
Project Status:
Active
Therapeutic Area:
Alagille syndrome
Manufacturer:
Medison Pharma Canada Inc.
Call for patient/clinician input open:
Brand Name:
Bylvay
Project Line:
Reimbursement Review
Project Number:
SR0884-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Odevixibat is indicated for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS).
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
​Odevixibat is indicated for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS).
  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 open20-Jan-25
Call for patient/clinician input closed18-Mar-25
Submission received28-Feb-25
Submission accepted19-Mar-25
Clarification:

- Submission was not accepted for review on 17 Mar 2025

Review initiated20-Mar-25
Draft CADTH review report(s) provided to sponsor for comment05-Jun-25
Deadline for sponsors comments16-Jun-25
CDA-AMC review report(s) and responses to comments provided to sponsor11-Jul-25
Expert committee meeting (initial)23-Jul-25
Draft recommendation issued to sponsorAugust 05, 2025
To
August 07, 2025
Draft recommendation posted for stakeholder feedback14-Aug-25
End of feedback period28-Aug-25

Files

Patient and Clinician Group Input View PDF
Last Updated : April 28, 2025