Last Updated : April 14, 2025
Details
FilesGeneric Name:
nemolizumab
Project Status:
Active
Therapeutic Area:
atopic dermatitis
Manufacturer:
Galderma Canada Inc.
Call for patient/clinician input open:
Brand Name:
TBC
Project Line:
Reimbursement Review
Project Number:
SR0869-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of moderate-to-severe AD in patients aged 12 years and
older whose disease is not adequately controlled with topical prescription
therapies or when those therapies are not advisable, and/or who are refractory
to or ineligible for systemic immunosuppressant therapies.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
For the treatment of moderate-to-severe atopic dermatitis (AD) in patients
aged 12 years and older who are candidates for systemic therapy.
- 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 | January 15, 2025 |
|---|---|
| Call for patient/clinician input closed | March 10, 2025 |
| Submission received | February 27, 2025 |
| Submission accepted | March 13, 2025 |
| Review initiated | March 17, 2025 |
| Draft CADTH review report(s) provided to sponsor for comment | June 02, 2025 |
| Deadline for sponsors comments | June 11, 2025 |
| CDA-AMC review report(s) and responses to comments provided to sponsor | July 11, 2025 |
| Expert committee meeting (initial) | July 23, 2025 |
| Draft recommendation issued to sponsor | August 05, 2025 To August 07, 2025 |
| Draft recommendation posted for stakeholder feedback | August 14, 2025 |
| End of feedback period | August 28, 2025 |
Files
Last Updated : April 14, 2025