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eculizumab

Last Updated: April 23, 2020
Result type: Reports
Project Number: SR0605-000
Product Line: Common Drug Review

Generic Name: eculizumab

Brand Name: Soliris

Manufacturer: Alexion Pharma Canada Corp.

Indications: Myasthenia Gravis (gMG), adults

Manufacturer Requested Reimbursement Criteria1: Soliris is indicated in adult patients with generalized Myasthenia Gravis (gMG).

Submission Type: New Indication

Project Status: Active

Biosimilar: No

Companion Diagnostics: No

Fee Schedule: Schedule B

  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.

Key Milestones2

Call for patient input open March 04, 2020
Call for patient input closed April 23, 2020
Clarification:

- Patient input submission received from the Muscular Dystrophy Canada

Submission received April 01, 2020
Submission accepted April 16, 2020
Review initiated April 17, 2020
Draft CADTH review report(s) provided to sponsor for comment July 02, 2020
Deadline for sponsors comments July 13, 2020
CADTH responses on draft review report(s) provided to sponsor August 07, 2020
Expert committee meeting (initial) August 19, 2020
Draft recommendation issued August 31, 2020
To
September 02, 2020