Regulatory Decision Summary for Cimzia
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.
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What was the purpose of this submission?
The purpose of this submission was to seek market authorization for Cimzia for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with evidence of objective signs of inflammation who have had an inadequate response to, or are intolerant to, non-steroidal anti-inflammatory drugs (NSAIDs).
Why was the decision issued?
This submission supports Cimzia use in adult patients with non-radiographic axial spondyloarthritis (nr-axSpA) who have had inadequate control or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs). Authorization was based on the results from a randomized controlled trial (Study AS0006) that included 317 adult subjects with active nr-axSpA who had inadequate response to, or were intolerant to, at least 2 NSAIDs.
Eligible subjects were randomized 1:1 to placebo or Cimzia 200 mg every 2 weeks following a loading dose (Cimzia 400 mg at Weeks 0, 2 and 4). The primary endpoint was the proportion of subjects achieving an Ankylosing spondylitis Disease Activity Score-Major Improvement (ASDAS-MI) response at Week 52. The ASDAS is a composite endpoint evaluating disease activity, including patient-reported outcomes and objective signs of inflammation. The secondary endpoint was the proportion of subjects who achieved at least a 40% improvement in a SpondyloArthritis International Society response criteria (ASAS40) at Week 12.
The primary results showed that a higher proportion of Cimzia-treated subjects achieved a major improvement as measured by the ASDAS-MI than placebo-treated subjects. In addition, a higher proportion of Cimzia-treated patients achieved an ASAS40 response at Week 12 compared to placebo-treated patients.
The safety profile for Cimzia in adult patients with nr-axSpA was similar to the safety profile for ankylosing spondylitis.
The overall benefit-risk profile of Cimzia as a treatment for patients with active nr-axSpA who are intolerant to, or have had an inadequate response to, NSAIDs is favorable.
Decision issued
Approved; Notice of Compliance recommended