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safinamide

Last Updated: June 12, 2019
Result type: Reports
Project Number: SR0617-000
Product Line: Common Drug Review

Generic Name: safinamide

Brand Name: Onstryv

Manufacturer: Valeo Pharma Inc.

Indications: Parkinson's disease

Manufacturer Requested Reimbursement Criteria1: Onstryv (safinamide tablets) is indicated as an add-on therapy to a regimen that includes levodopa for the treatment of the signs and symptoms of idiopathic Parkinson’s disease (PD) in patients experiencing off episodes while on a stable dose of levodopa. Onstryv has not been shown to be effective as monotherapy for the treatment of PD.

Submission Type: New

Project Status: Active

Biosimilar: No

Fee Schedule: Pending

  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.

Key Milestones2

Call for patient input postedApril 30, 2019
Patient group input closedJune 19, 2019
Patient input summary sent for review to patient input groups-
Patient group comments on input summary closed-
Submission receivedMay 29, 2019
Submission accepted for reviewJune 12, 2019
Review initiatedJune 18, 2019
Draft CADTH review report(s) sent to applicant-
Comments from applicant on draft CADTH review report(s) received-
CADTH review team's comments on draft CADTH review report(s) sent to applicant-
Canadian Drug Expert Committee (CDEC) meeting-
CDEC recommendation sent to applicant and drug plans-
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