nemolizumab

Details

Generic Name:
nemolizumab
Project Status:
Active
Therapeutic Area:
Prurigo nodularis (PN)
Manufacturer:
Galderma Canada Inc.
Call for patient/clinician input open:
Brand Name:
TBC
Project Line:
Reimbursement Review
Project Number:
SR0861-000
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 prurigo nodularis (PN).
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
For the treatment of moderate-to-severe prurigo nodularis (PN).
  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 openNovember 21, 2024
Call for patient/clinician input closedJanuary 17, 2025
Submission receivedJanuary 07, 2025
Submission acceptedJanuary 21, 2025
Review initiatedJanuary 22, 2025
Draft Canada's Drug Agency review report(s) provided to sponsor for commentApril 09, 2025
Deadline for sponsors commentsApril 22, 2025
Canada's Drug Agency review report(s) and responses to comments provided to sponsorMay 15, 2025
Expert committee meeting (initial)May 28, 2025
Draft recommendation issued to sponsorJune 09, 2025
To
June 11, 2025
Draft recommendation posted for stakeholder feedbackJune 19, 2025
End of feedback periodJuly 04, 2025