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isavuconazole

Last Updated: December 21, 2018
Result type: Reports
Project Number: SR0586-000
Product Line: Common Drug Review

Generic Name: isavuconazole

Brand Name: Cresemba

Manufacturer: AVIR Pharma Inc.

Indications: Treatment of invasive aspergillosis and mucormycosis

Manufacturer Requested Reimbursement Criteria1: For use in adults for the treatment of: Invasive aspergillosis Invasive mucormycosis

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 postedOctober 04, 2018
Patient group input closedNovember 23, 2018
Clarification:

- No patient input submission received

Submission receivedNovember 02, 2018
Submission accepted for reviewNovember 16, 2018
Review initiatedNovember 22, 2018
Draft CADTH review report(s) sent to applicantFebruary 12, 2019
Comments from applicant on draft CADTH review report(s) receivedFebruary 22, 2019
Redaction requests from applicant on draft CADTH review report(s) receivedMarch 05, 2019
Clarification:

- Extension requested by applicant

- Request granted

CADTH review team's comments on draft CADTH review report(s) sent to applicantMarch 29, 2019
Canadian Drug Expert Committee (CDEC) meetingApril 10, 2019
CDEC recommendation & redacted CADTH review report(s) sent to applicant and drug plansApril 23, 2019
To
April 25, 2019