Regulatory Decision Summary for Sotyktu
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.
Type of Submission:
New Drug Submission
Authorized; issued a Notice of Compliance in accordance with the Food and Drug Regulations
What was the purpose of this submission?
The purpose of this New Drug Submission (NDS) is to request marketing approval for the New Active Substance (NAS) deucravacitinib, marketed as Sotyktu, for patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. It is a film-coated selective immunosuppressant tablet containing 6 mg of the active substance, intended for once daily oral administration.
Why was the decision issued?
Sotyktu (deucravacitinib), administered once-daily as a 6 mg oral tablet, was shown to be efficacious and safe in two phase 3 randomised, double-blinded, placebo and active-comparator controlled pivotal trials. Both had similar study designs and were conducted in participants with moderate to severe plaque psoriasis with and without prior systemic therapy. The co-primary endpoints of both studies were Static Physician’s Global Assessment 0/1 (sPGA0/1), which indicates a clear or almost clear appearance of psoriasis lesions, and Psoriasis Severity Area Index (PASI) 75, which represents a 75% reduction in psoriasis symptoms and body surface area, compared to baseline at week 16 of treatment. In both studies, statistical significance demonstrating superiority of Sotyktu over placebo was achieved for both co-primary endpoints at Week 16. Sotyktu also achieved statistically significant higher response rates compared with the active comparator, apremilast, at Week 16. These endpoints are considered standard, clinically meaningful measurements of plaque psoriasis disease burden and symptom severity.
Sotyktu was generally well-tolerated. Treatment-emergent adverse events (AEs) were generally mild or moderate and few resulted in withdrawal of study drug. Infections, the most common adverse events, were predominantly mild or moderate in intensity and not systemic. They occurred more frequently with Sotyktu (29.1%) compared with placebo (21.5%) or apremilast (22.0%) through Week 16. The incidence of serious AEs (SAEs) was low and similar across treatment groups, occurring in single participants. Similar results were obtained through 52 weeks of treatment. No new safety signals emerged with longer exposure.
Similar efficacy and safety profiles were observed across various sub-populations based on age, sex, race, body weight, disease severity and geographic location.
The non-clinical pharmacology, pharmacokinetic and toxicology assessments were appropriate in establishing a suitable clinical safety margin and did not raise any major safety concern.
Uncertainties with Sotyktu include a hypothetical role in the development of malignancies based on its mechanism of action as an immunosuppressant; risks with use during pregnancy or breastfeeding; and concomitant use with other immunosuppressants. Modest signals for elevations in blood transaminases, creatine kinase and triglycerides were also added to the label. The approved Sotyktu label appropriately mitigates risk.
Sotyktu may be administered without regard to food, though overall exposure and absorption was modestly decreased following a high-fat high-calorie meal.
A risk management plan was submitted and reviewed by the Marketed Health Products Directorate and found to be acceptable.
Sotyktu offers a therapeutic option with a novel mechanism of action as a once-daily single dose tablet for patients who were and were not previously treated with other systemic therapies. The benefit-risk profile for Sotyktu is considered acceptable for adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
For further details about Sotyktu, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.
Date of Decision:
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Drug Identification Number(s) Issued:
Available by prescription only