Last Updated : July 22, 2025
Details
Generic Name:
nipocalimab
Project Status:
Pending
Therapeutic Area:
Generalized myasthenia gravis (gMG)
Manufacturer:
Janssen Inc.
Call for patient/clinician input open:
Brand Name:
TBC
Project Line:
Reimbursement Review
Project Number:
SR0905-000
Call for patient/clinician input closed:
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Add-on therapy for antibody positive (AChR, MuSK, or LRP4) adult (≥18 years) and adolescent (12 to 18 years) gMG patients whose symptoms persist despite adequate treatment with acetylcholinesterase inhibitors (AChEIs), corticosteroids,
and/or non-steroidal immunosuppressants (NSISTs).
Submission Type:
Initial
Fee Schedule:
Pending
Indications:
Treatment of generalized myasthenia gravis (gMG) in adults (≥18 years) and adolescent patients (12 to 18 years) who are antibody positive (anti-acetylcholine receptor [AChR], anti-muscle-specific tyrosine kinase [MuSK], or anti-low-density
lipoprotein receptor-related protein 4 [LRP4]).
Anticipated Date:
- 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.
Last Updated : July 22, 2025