Canada’s Drug Agency | Drugs, Health Technologies and Systems.

pegunigalsidase alfa

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Generic Name:
pegunigalsidase alfa
Project Status:
Active
Therapeutic Area:
Fabry disease
Manufacturer:
Chiesi Canada Corp.
Call for patient/clinician input open:
Brand Name:
TBC
Project Line:
Reimbursement Review
Project Number:
SR0872-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Long-term enzyme replacement therapy in adult patients with a confirmed diagnosis of Fabry disease (deficiency of alpha-galactosidase).
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
​Long-term enzyme replacement therapy in adult patients with a confirmed diagnosis of Fabry disease (deficiency of alpha-galactosidase).
  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.
Key Milestones2
Call for patient/clinician input open06-Feb-25
Call for patient/clinician input closed31-Mar-25
Submission received04-Apr-25
Submission accepted22-Apr-25
Review initiated23-Apr-25
Draft CADTH review report(s) provided to sponsor for comment08-Jul-25
Deadline for sponsors comments17-Jul-25
CDA-AMC review report(s) and responses to comments provided to sponsor15-Aug-25
Expert committee meeting (initial)27-Aug-25
Draft recommendation issued to sponsorSeptember 09, 2025
To
September 11, 2025
Draft recommendation posted for stakeholder feedback18-Sep-25
End of feedback period03-Oct-25

Files

Patient and Clinician Group Input View PDF
Last Updated : April 23, 2025