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lixisenatide

Last Updated: December 11, 2017
Result type: Reports
Project Number: SR0520-000
Product Line: Common Drug Review

Generic Name: lixisenatide

Brand Name: Adlyxine

Manufacturer: Sanofi-aventis Canada Inc.

Indications: Diabetes mellitus, Type 2

Submission Type: New

Project Status: Active

Biosimilar: No

Date Recommendation Issued: November 23, 2017

Recommendation Type: Reimburse with clinical criteria and/or conditions

Fee Schedule1: Schedule A

Key Milestones2

Call for patient input posted3April 26, 2017
Patient group input closed3June 15, 2017
Clarification:

- Patient input submission received

Patient input summary sent for review to patient input groupsJune 20, 2017
Patient group comments on input summary closedJune 27, 2017
Clarification:

- No patient input summary feedback received

Submission receivedMay 29, 2017
Submission accepted for reviewJune 12, 2017
Review initiatedJune 13, 2017
Draft CDR review report(s) sent to applicantSeptember 05, 2017
Comments from applicant on draft CDR review report(s) receivedSeptember 14, 2017
Redaction requests from applicant on draft CDR review report(s) receivedSeptember 21, 2017
CDR review team's comments on draft CDR review report(s) sent to applicantOctober 05, 2017
Canadian Drug Expert Committee (CDEC) meetingOctober 18, 2017
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plansOctober 31, 2017
Embargo4 period ended and validation of redacted CDR review report(s) receivedNovember 14, 2017
CDEC Final Recommendation issued to applicant and drug plansNovember 21, 2017
CDEC Final Recommendation posted5November 23, 2017
Final CDR review report(s) and patient input posted5-

Tags

diabetes, Diabetes; Diabetic; lixisenatide; Adlyxine; Adlyxin; Lyxumia