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dupilumab

Last Updated: January 2, 2018
Result type: Reports
Project Number: SR0533-000
Product Line: Common Drug Review

Generic Name: dupilumab

Brand Name: Dupixent

Manufacturer: Sanofi-Genzyme

Indications: atopic dermatitis

Submission Type: New

Project Status: Active

Biosimilar: No

Fee Schedule1: Schedule A

Key Milestones2

Call for patient input posted3August 15, 2017
Patient group input closed3October 04, 2017
Clarification:

- Patient input submission received

Patient input summary sent for review to patient input groupsNovember 16, 2017
Patient group comments on input summary closedNovember 21, 2017
Clarification:

- Patient input summary feedback received

Submission receivedOctober 27, 2017
Submission accepted for reviewNovember 10, 2017
Review initiatedNovember 13, 2017
Draft CDR review report(s) sent to applicantFebruary 01, 2018
Comments from applicant on draft CDR review report(s) receivedFebruary 12, 2018
Redaction requests from applicant on draft CDR review report(s) receivedFebruary 20, 2018
CDR review team's comments on draft CDR review report(s) sent to applicantMarch 09, 2018
Canadian Drug Expert Committee (CDEC) meetingMarch 21, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plansApril 03, 2018
To
April 05, 2018
  1. Refer to Appendix 1 of the Procedure for the CADTH Common Drug Review for details regarding CDR application fee schedules.
  2. Please refer to the Procedure for the CADTH Common Drug Review for complete details regarding the CDR process and targeted time frames for key milestones.
  3. The call for patient group input is posted 20 business days in advance of the applicant's anticipated date of filing the CDR application. Patient groups have a total of 35 business days for preparing and submitting patient input.
  4. The embargoed CDEC recommendation is held in confidence by all stakeholders and not acted upon until after CADTH has issued the notice of CDEC Final Recommendation.The applicant may make a request for reconsideration or resubmission based on reduced price during the embargo period, and the drug plans may make a request for clarification, as applicable (see section 8 of the Procedure for the CADTH Common Drug Review).
  5. The timing for posting the CDEC Final Recommendation and CDR review report(s) depends on several factors including the need for consultation with the applicant regarding redaction issues.
  6. The time frame required to address a request for clarification at the drug plans' request or request for reconsideration at the applicant's request depends on the amount of work required to address the request and the available dates for CDEC meetings.

Tags

dermatology, dermatitis, atopic, dupilumab; dupixent; Dermatitis; eczema