Last Updated : October 22, 2024
Details
FilesGeneric Name:
rozanolixizumab
Project Status:
Active
Therapeutic Area:
Generalized myasthenia gravis (gMG)
Manufacturer:
UCB Canada Inc.
Call for patient/clinician input open:
Brand Name:
TBC
Project Line:
Reimbursement Review
Project Number:
SR0846-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
As an add-on therapy for the treatment of adult patients with gMG who are either acetylcholine receptor (AChR) or muscle-specific kinase (MuSK) antibody positive and for whom symptoms persist despite conventional therapy with acetylcholinesterase inhibitors (AChEIs), corticosteroids, and/or non-steroidal immunosuppressive therapies (NSISTs).
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
For the treatment of generalized myasthenia gravis (gMG) in adult patients.
- 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 | 21-Mar-24 |
|---|---|
| Call for patient/clinician input closed | 13-May-24 |
| Submission received | 02-Aug-24 |
| Submission accepted | 19-Aug-24 |
| Review initiated | 20-Aug-24 |
| Draft CADTH review report(s) provided to sponsor for comment | 28-Nov-24 |
| Deadline for sponsors comments | 09-Dec-24 |
| CADTH review report(s) and responses to comments provided to sponsor | 10-Jan-25 |
| Expert committee meeting (initial) | 22-Jan-25 |
| Draft recommendation issued to sponsor | February 04, 2025 To February 06, 2025 |
| Draft recommendation posted for stakeholder feedback | 13-Feb-25 |
| End of feedback period | 28-Feb-25 |
Files
Last Updated : October 22, 2024