Regulatory Decision Summary for ORENCIA
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 supplemental new drug submission (SNDS) is to seek authorization for the use of Orencia (abatacept) in the treatment of adult patients with active psoriatic arthritis.
Why was the decision issued?
Orencia (abatacept) was investigated in two randomized, double-blind, placebo-controlled trials: the main study involved 424 adult patients with active (≥3 swollen joints and ≥3 tender joints) psoriatic arthritis (PsA) and the supportive study involved 170 adults with active PsA. 61% of subjects in the main study and 37% of subjects in the supportive study were previously treated with TNFi. At randomization, approximately 60% of patients in the main and the supportive study were receiving methotrexate. Stable doses of non-biologic DMARDs (such as methotrexate) and PsA medications (e.g. non-steroidal anti-inflammatory drugs [NSAIDs]) were continued during the trials.
The main study showed that a higher proportion of Orencia-treated subjects had improvement (reduction) in symptoms of PsA defined as 20% improvement in their arthritis as measured by the American College of Rheumatology (ACR20) compared to placebo-treated patients during the 24-weeks treatment period (39.4% vs. 22.3%, respectively, for an estimate of difference in proportions of 17.2% [8.7%, 25.6%]95%CI).
Similarly, the supportive study showed a higher proportion of Orencia-treated subjects had improvement in symptoms of PsA (ACR20) compared to placebo-treated subjects during the 24-week treatment period (47.5% vs. 19.0%, respectively, for an estimate of difference in proportions of 28.7% [9.4%, 48.0%]95% CI).
The safety profile of Orencia use in psoriatic arthritis patients was comparable to the safety profile of placebo during the 6-months study periods; the long-term safety profile of Orencia use in psoriatic arthritis was comparable to its currently approved use in rheumatoid arthritis patients.
The benefit/risk profile of Orencia in adults with psoriatic arthritis is considered acceptable.
In addition, Orencia works differently from current approved psoriatic arthritis medications. Its approval would offer a treatment option to patients whose psoriatic arthritis is not adequately controlled on current medications.
A Notice of compliance (NOC) is recommended.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.