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sebelipase alfa

Last Updated: October 11, 2018
Result type: Reports
Project Number: SR0544-000
Product Line: Common Drug Review

Generic Name: sebelipase alfa

Brand Name: Kanuma

Manufacturer: Alexion Pharmaceuticals

Indications: Lysosomal acid lipase deficiency

Submission Type: New

Project Status: Active

Biosimilar: No

Date Recommendation Issued: September 26, 2018

Recommendation Type: Reimburse with clinical criteria and/or conditions

Fee Schedule: Schedule A

Key Milestones2

Call for patient input postedOctober 04, 2017
Patient group input closedNovember 23, 2017
Clarification:

- Patient input submission received

Patient input summary sent for review to patient input groupsDecember 04, 2017
Patient group comments on input summary closedDecember 11, 2017
Clarification:

- Patient input summary feedback received

Submission receivedNovember 02, 2017
Submission accepted for reviewNovember 16, 2017
Review initiatedNovember 17, 2017
Draft CDR review report(s) sent to applicantFebruary 16, 2018
Comments from applicant on draft CDR review report(s) receivedMarch 02, 2018
Clarification:

- Extension request received from applicant

- Extension granted

Redaction requests from applicant on draft CDR review report(s) receivedMarch 09, 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 25, 2018
Embargo period ended and validation of redacted CDR review report(s) receivedJune 07, 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 agendaSeptember 19, 2018
CDEC Final Recommendation issued to applicant and drug plansSeptember 26, 2018
CDEC Final Recommendation postedSeptember 28, 2018
Final CDR review report(s) and patient input posted-

Tags

genetics, pediatrics, cholesterol ester storage disease, dyslipidemias, wolman disease, sebelipase alfa; lysosomal disorder