Regulatory Decision Summary for Kevzara
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
Product type:
Medicinal ingredient(s):
Therapeutic area:
Type of submission:
Control number:
What was the purpose of this submission?
The purpose of the submission was to provide Study EFC14092 (MONARCH) in support of Kevzara use as monotherapy in the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs).
The results of MONARCH were found to be insufficient to support the proposed claim.
In response to a request for additional information, the sponsor submitted additional analyses of MONARCH data, a reference and real world data (RWD) including patient registry and proposed a revised indication.
Why was the decision issued?
After a careful review of the data provided, the additional information (analyses, reference and real world data) were considered insufficient to support Kevzara monotherapy in methotrexate (MTX) intolerant, contraindicated or inadequate responders.
However to align with the Product Monographs (PMs) of the similar drug, the previously-approved statement regarding the use of Kevzara monotherapy in MTX intolerant/inappropriate patients (below) was moved from the Dosing and Administration section of the PM to the indication section. No additional scientific data was added to the PM.
"Kevzara should be used in combination with methotrexate (MTX) or other traditional DMARDs. Kevzara may be given as monotherapy in cases of intolerance or contraindication to methotrexate or DMARDs."
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.