filgotinib

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Withdrawn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.
  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 input openJuly 06, 2020
Call for patient input closedAugust 25, 2020
Clarification:

- Patient input submission received from the Arthritis Society and Canadian Arthritis Patient Alliance (Joint) and Arthritis Consumer Experts

Submission receivedAugust 04, 2020
Clarification:

- Submission was not accepted for review on 18 Aug 2020

- Voluntarily withdrawn by the sponsor on 4 Feb 2021