Last Updated : February 5, 2021
Details
Generic Name:
filgotinib
Project Status:
Withdrawn
Therapeutic Area:
Arthritis, Rheumatoid
Manufacturer:
Gilead Sciences Canada, Inc.
Brand Name:
TBC
Project Line:
Reimbursement Review
Project Number:
SR0656-000
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Indicated as monotherapy, or in combination with methotrexate (MTX) or other conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), for reducing signs and symptoms of moderate to severe rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs.
Submission Type:
Initial
Fee Schedule:
Pending
Indications:
Indicated as monotherapy, or in combination with methotrexate (MTX) or other conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), for reducing signs and symptoms of moderate to severe rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs.
- 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 input open | July 06, 2020 |
| Call for patient input closed | August 25, 2020 |
| Clarification: - Patient input submission received from the Arthritis Society and Canadian Arthritis Patient Alliance (Joint) and Arthritis Consumer Experts | |
| Submission received | August 04, 2020 |
| Clarification: - Submission was not accepted for review on 18 Aug 2020 - Voluntarily withdrawn by the sponsor on 4 Feb 2021 | |
Last Updated : February 5, 2021