Last Updated : February 5, 2025
Details
FilesGeneric Name:
trofinetide
Project Status:
Active
Therapeutic Area:
Rett syndrome (RTT)
Manufacturer:
Acadia Pharmaceuticals Canada Inc.
Call for patient/clinician input open:
Brand Name:
Daybue
Project Line:
Reimbursement Review
Project Number:
SR0829-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of Rett syndrome (RTT) in adults and pediatric patients 2 years of age and older and weighing at least 9 kg.
Submission Type:
Initial
Companion Diagnostics:
Yes
Fee Schedule:
Schedule E
Indications:
For the treatment of Rett syndrome (RTT) in adults and pediatric patients 2 years of age and older and weighing at least 9 kg.
- 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 | August 16, 2024 |
|---|---|
| Call for patient/clinician input closed | October 15, 2024 |
| Submission received | October 29, 2024 |
| Submission accepted | November 13, 2024 |
| Review initiated | November 14, 2024 |
| Draft CADTH review report(s) provided to sponsor for comment | February 05, 2025 |
| Deadline for sponsors comments | February 14, 2025 |
| CADTH review report(s) and responses to comments provided to sponsor | March 13, 2025 |
| Expert committee meeting (initial) | March 26, 2025 |
| Draft recommendation issued to sponsor | April 07, 2025 To April 09, 2025 |
| Draft recommendation posted for stakeholder feedback | April 17, 2025 |
| End of feedback period | May 05, 2025 |
Files
Last Updated : February 5, 2025