Regulatory Decision Summary for HUMIRA
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 Supplement to a New Drug Submission (SNDS) was to seek market authorization of HUMIRA for the treatment of active moderate to severe hidradenitis suppurativa in adult patients who have not responded to conventional therapy (including systemic antibiotics).
Why was the decision issued?
The efficacy and safety of HUMIRA (adalimumab) were based on two phase 3, placebo-controlled clinical trials. The results obtained from these trials showed that the treatment with HUMIRA in adult patients with moderate to severe Hiradenitis Suppurrativa (HS) reduces the inflammatory lesions (nodules and abscesses) of this condition.
The recommended initial dose is 160 mg, followed by a second dose of 80 mg two weeks later. The recommended maintenance dose regimen (after the second dose) is 40 mg every week beginning four weeks after the initial dose. HUMIRA is administered subcutaneously.
The safety profile of HUMIRA in the studied HS population is comparable to that known for other patient populations for whom HUMIRA is authorized in Canada. No new safety signals were detected. Therefore, the overall Benefit/Risk of HUMIRA for the indication authorized above is considered favourable.
In order to ensure that the benefit continues to outweigh any risk after authorization, Health Canada has required from the Sponsor to continue implementing the current Risk Management Plan.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations.