Last Updated : February 5, 2025
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 | March 21, 2024 |
|---|---|
| Call for patient/clinician input closed | May 13, 2024 |
| Submission received | August 02, 2024 |
| Submission accepted | August 19, 2024 |
| Review initiated | August 20, 2024 |
| Draft CADTH review report(s) provided to sponsor for comment | November 28, 2024 |
| Deadline for sponsors comments | December 09, 2024 |
| CADTH review report(s) and responses to comments provided to sponsor | January 10, 2025 |
| Expert committee meeting (initial) | January 22, 2025 |
| Draft recommendation issued to sponsor | - |
| Clarification: CDEC recommendation held pending receipt of NOC and evaluation of the finalized submission requirements | |
| Draft recommendation posted for stakeholder feedback | - |
| End of feedback period | - |
Files
Last Updated : February 5, 2025