Last Updated : October 10, 2024
Details
Generic Name:
leniolisib
Project Status:
Suspended
Therapeutic Area:
Activated phosphoinositide 3 kinase delta syndrome
Manufacturer:
Pharming Technologies BV
Call for patient/clinician input open:
Brand Name:
TBC
Project Line:
Reimbursement Review
Project Number:
SR0792-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Pharming requests reimbursement for leniolisib for the treatment of APDS in adults and adolescents 12 years of age and older.
Submission Type:
Initial
Fee Schedule:
Schedule E
Indications:
Indicated for the treatment of activated phosphoinositide 3 kinase delta syndrome (APDS) in adults and adolescents 12 years of age and older..
- 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 | 07-Mar-24 |
|---|---|
| Call for patient/clinician input closed | 30-Apr-24 |
| Clarification: - Patient input submission received from the Canadian Immunodficiencies Patient Organization (operating as Immunity Canada) | |
| Submission received | 19-Apr-24 |
| Submission accepted | 06-May-24 |
| Review initiated | 07-May-24 |
| Draft CADTH review report(s) provided to sponsor for comment | 22-Jul-24 |
| Clarification: - Submission temporarily suspended | |
Last Updated : October 10, 2024