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safinamide

Last Updated: September 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: Schedule A

  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
Clarification:

- Patient input submission received from Parkinson Canada and Parkinson Society of BC

Patient input summary sent for review to patient input groupsJune 26, 2019
Patient group comments on input summary closedJuly 04, 2019
Clarification:

- Patient input summary feedback received

Submission receivedMay 29, 2019
Submission accepted for reviewJune 12, 2019
Review initiatedJune 18, 2019
Draft CADTH review report(s) sent to sponsorSeptember 03, 2019
Comments from sponsor on draft CADTH review report(s) receivedSeptember 12, 2019
CADTH review team's comments on draft CADTH review report(s) sent to sponsorOctober 03, 2019
Canadian Drug Expert Committee (CDEC) meetingOctober 16, 2019
CDEC recommendation sent to sponsor and drug plansOctober 28, 2019
To
October 30, 2019