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edaravone

Last Updated: December 14, 2018
Result type: Reports
Project Number: SR0573-000
Product Line: Common Drug Review

Generic Name: edaravone

Brand Name: Radicava

Manufacturer: Mitsubishi Tanabe Pharma Corporation

Indications: amyotrophic lateral sclerosis

Manufacturer Requested Reimbursement Criteria1: For the treatment of amyotrophic lateral sclerosis (ALS).

Submission Type: New

Project Status: Active

Biosimilar: No

Companion Diagnostics: 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 postedMay 25, 2018
Patient group input closedJuly 16, 2018
Clarification:

- Patient input submission received from the ALS Society of Canada

Patient input summary sent for review to patient input groupsJuly 31, 2018
Patient group comments on input summary closedAugust 08, 2018
Clarification:

- Patient input summary feedback received

Submission receivedJuly 05, 2018
Submission accepted for reviewJuly 19, 2018
Review initiatedJuly 20, 2018
Draft CDR review report(s) sent to applicantOctober 04, 2018
Comments from applicant on draft CDR review report(s) receivedOctober 16, 2018
Redaction requests from applicant on draft CDR review report(s) receivedOctober 23, 2018
CDR review team's comments on draft CDR review report(s) sent to applicantNovember 09, 2018
Canadian Drug Expert Committee (CDEC) meetingNovember 21, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plansDecember 05, 2018
Embargo period ended and validation of redacted CDR review report(s) receivedJanuary 24, 2019
Clarification:

- Request for extension to embargo period received from the manufacturer

- Embargo extension request granted

Tags

nervous system