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 SNDS was to obtain authorization of Humira (adalimumab) for the treatment of active moderate to severe hidradenitis suppurativa in adolescent patients (12 to 17 years of age weighing ≥ 30 kg) who have not responded to conventional therapy (including systemic antibiotics).
Hidradenitis suppurativa is a rare condition in adolescents, and this submission proposed a full pharmacokinetic and pharmacokinetic-pharmacodynamic extrapolation approach in lieu of clinical trials. The adult indication was authorized in 2015.
Why was the decision issued?
Authorization for hidradenitis suppurativa in adolescent patient (12 to 17 years of age weighing ≥ 30 kg) who have not responded to conventional therapy was based on data extrapolation from the currently authorized indications for Humira.
Efficacy results were derived from exposure-response relationship data from adult hidradenitis suppurativa patients in which the benefit-risk profile has been well-established by adequate and well-controlled studies. Use of extrapolation and modeling was an accepted method given the similar disease pathophysiology and progression between adolescents and adults and the challenges in conducting clinical trials in adolescent hidradenitis suppurativa patients due to the rarity of the disease. The dosing regimen in adolescent hidradenitis suppurativa patients of 80 mg at Week 0 followed by 40 mg every other week starting at Week 1 was shown to provide similar efficacy as in adult hidradenitis suppurativa patients. Dosing for patients with inadequate response can be increased to 40 mg every week in some cases.
Extensive safety data on pediatric use of Humira are available from clinical trials conducted in pediatric populations as well as from post-marketing experience for polyarticular juvenile idiopathic arthritis, enthesitis-related arthritis, pediatric psoriasis, and pediatric Crohns disease. Pooled analyses based on pediatric clinical data for Humira suggest a lack of safety issues during the extrapolation to adolescent hidradenitis suppurativa patients. The safety profile is expected to be consistent with adult data.
Modeling and extrapolation of data for the use of Humira in adolescent hidradenitis suppurativa patients was based on the assumption of similar pathophysiology between adolescents and adults, which is considered acceptable. The benefit-risk profile for adolescent patients with active moderate to severe hidradenitis suppurativa who have not responded to conventional therapy is considered positive, particularly since Humira has a well-established profile in various pediatric and adult conditions and formal clinical trials in this patient population pose significant challenges.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.