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dupilumab

Last Updated: June 4, 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 Schedule: Schedule A

Key Milestones2

Call for patient input postedAugust 15, 2017
Patient group input closedOctober 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
Clarification:

- Submission temporarily suspended pending receipt of information

- Additional information has been received and the temporary suspension of the review has been lifted

Draft CDR review report(s) sent to applicantFebruary 20, 2018
Comments from applicant on draft CDR review report(s) receivedMarch 01, 2018
Redaction requests from applicant on draft CDR review report(s) receivedMarch 08, 2018
CDR review team's comments on draft CDR review report(s) sent to applicantMarch 29, 2018
Canadian Drug Expert Committee (CDEC) meetingApril 11, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plansApril 24, 2018
Embargo period ended and validation of redacted CDR review report(s) receivedMay 15, 2018
Clarification:

- Request for extension to embargo period received from the manufacturer

- Embargo extension request granted

- Reconsideration requested

Applicant's request for reconsideration placed on CDEC agendaJune 20, 2018
CDEC Final Recommendation issued to applicant and drug plansJune 27, 2018
CDEC Final Recommendation posted-
Final CDR review report(s) and patient input posted-

Tags

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