mirikizumab

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Generic Name:
mirikizumab
Project Status:
Active
Therapeutic Area:
Crohn’s disease
Manufacturer:
Eli Lilly Canada Inc.
Call for patient/clinician input open:
Brand Name:
Omvoh
Project Line:
Reimbursement Review
Project Number:
SR0880-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Eli Lilly Canada Inc. requests that Omvoh (mirikizumab) be funded as per the anticipated Health Canada indication.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Omvoh (mirikizumab) is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response, loss of response, or were intolerant to either conventional therapy or a biologic treatment.
  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 open16-Jan-25
Call for patient/clinician input closed18-Mar-25
Submission received04-Mar-25
Submission accepted19-Mar-25
Review initiated20-Mar-25
Draft CADTH review report(s) provided to sponsor for comment05-Jun-25
Deadline for sponsors comments16-Jun-25
CADTH 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