lemborexant

Details

Generic Name:
lemborexant
Project Status:
Received
Therapeutic Area:
Insomnia
Manufacturer:
Eisai Limited
Call for patient/clinician input open:
Brand Name:
Dayvigo
Project Line:
Reimbursement Review
Project Number:
SR0895-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of insomnia in adults diagnosed according to the most recent version of the Diagnostic and Statistical Manual of Mental Disorders (DSM) referring to chronic insomnia disorder (CID)
Submission Type:
Resubmission
Fee Schedule:
Pending
Indications:
The treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.
  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 open28-Feb-25
Call for patient/clinician input closed29-Apr-25
Submission received10-Apr-25
Submission accepted-