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lixisenatide

Last Updated: February 13, 2018
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: Complete

Biosimilar: No

Date Recommendation Issued: November 23, 2017

Recommendation Type: Reimburse with clinical criteria and/or conditions

Fee Schedule: Schedule A

Key Milestones2

Call for patient input posted3 April 26, 2017
Patient group input closed3 June 15, 2017
Clarification:

- Patient input submission received

Patient input summary sent for review to patient input groups June 20, 2017
Patient group comments on input summary closed June 27, 2017
Clarification:

- No patient input summary feedback received

Submission received May 29, 2017
Submission accepted for review June 12, 2017
Review initiated June 13, 2017
Draft CDR review report(s) sent to applicant September 05, 2017
Comments from applicant on draft CDR review report(s) received September 14, 2017
Redaction requests from applicant on draft CDR review report(s) received September 21, 2017
CDR review team's comments on draft CDR review report(s) sent to applicant October 05, 2017
Canadian Drug Expert Committee (CDEC) meeting October 18, 2017
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans October 31, 2017
Embargo4 period ended and validation of redacted CDR review report(s) received November 14, 2017
CDEC Final Recommendation issued to applicant and drug plans November 21, 2017
CDEC Final Recommendation posted5 November 23, 2017
Final CDR review report(s) and patient input posted5 December 21, 2017