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

nemolizumab

Details

Files
Generic 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.
  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 open15-Jan-25
Call for patient/clinician input closed10-Mar-25
Submission received27-Feb-25
Submission accepted13-Mar-25
Review initiated17-Mar-25
Draft CADTH review report(s) provided to sponsor for comment02-Jun-25
Deadline for sponsors comments11-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

Files

Patient and Clinician Group Input View PDF
Last Updated : March 18, 2025