Regulatory Decision Summary for Simponi I.V.
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 this Supplement to a New Drug Submission (SNDS) was to seek marketing authorization for Simponi I.V. for the treatment of adult patients with ankylosing spondylitis, and adult patients with active psoriatic arthritis. Upon review, the indications authorized were for the treatment of adult patients with ankylosing spondylitis who have had an inadequate response or intolerance to conventional therapies, and for the treatment of adult patients with moderately to severely active psoriatic arthritis.
Why was the decision issued?
The efficacy of Simponi I.V. in adults with ankylosing spondylitis and psoriatic arthritis was established in pivotal trials GO-ALIVE and GO-VIBRANT, respectively. The indications that were authorized reflected the characteristics of the subjects enrolled in these trials.
GO-ALIVE was a multicenter, randomized, double-blind, placebo-controlled trial which enrolled 208 adults with active ankylosing spondylitis and inadequate response or intolerance to non-steroidal anti-inflammatory drugs (NSAIDs). Its primary endpoint was the percentage of patients achieving an Assessment in Ankylosing Spondylitis (ASAS) 20 response at Week 16. 73.3% of subjects treated with Simponi I.V. achieved an ASAS 20 response at Week 16, compared with 26.2% of subjects treated with placebo.
GO-VIBRANT was a multicenter, randomized, double-blind, placebo-controlled trial which enrolled 480 subjects with active psoriatic arthritis. Its primary endpoint was the percentage of subjects having an American College of Rheumatology (ACR) 20 response at Week 14. 75.1% of subjects treated with Simponi I.V. achieved an ACR 20 response at Week 14, compared with 21.8% of subjects treated with placebo.
The risk profile of Simponi I.V. in adults with ankylosing spondylitis and psoriatic arthritis was acceptable.
Risk mitigation strategies are described in the Product Monograph. Key features include avoidance of the administration of SIMPONI I.V. to patients with active infections and avoidance of the administration of live vaccines to patients receiving Simponi I.V.
The Risk Management Plan (RMP) and the Canadian Addendum to the RMP were reviewed by the Marketed Health Products Directorate (MHPD) and found satisfactory. The key elements were commitment to ongoing pharmacovigilance activities and submission of mandated safety reports.
The safety and efficacy of Simponi I.V. have not been established in pediatric patients aged 17 and younger.
The overall benefit/risk profile of Simponi I.V. in adult patients with ankylosing spondylitis who have had an inadequate response or intolerance to conventional thera`pies and adult patients with moderately to severely active psoriatic arthritis is favourable.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.