sodium phenylbutyrate and ursodoxicoltaurine


( Last Updated : June 23, 2022)
Generic Name:
sodium phenylbutyrate and ursodoxicoltaurine
Project Status:
Active
Therapeutic Area:
Amyotrophic lateral sclerosis (ALS)
Manufacturer:
Amylyx Canada
Brand Name:
Albrioza
Project Line:
Reimbursement Review
Project Number:
SR0711-000
NOC Status at Filing:
Pre NOC

Details


Manufacturer Requested Reimbursement Criteria1:
For the treatment of patients with amyotrophic lateral sclerosis (ALS).
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
For the treatment of patients with amyotrophic lateral sclerosis (ALS).
  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.

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Key Milestones2

Call for patient/clinician input open 27-Oct-21
Call for patient/clinician input closed 16-Dec-21
Clarification:

- Patient input submission received from The ALS Society of Canada and ALS Action Canada

Submission received 24-Nov-21
Submission accepted 08-Dec-21
Review initiated 09-Dec-21
Draft CADTH review report(s) provided to sponsor for comment 07-Mar-22
Deadline for sponsors comments 16-Mar-22
CADTH review report(s) and responses to comments provided to sponsor 12-May-22
Expert committee meeting (initial) 25-May-22
Draft recommendation issued to sponsor 13-Jun-22
Draft recommendation posted for stakeholder feedback 23-Jun-22
End of feedback period 08-Jul-22