Regulatory Decision Summary for Skyrizi
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:
Contact:
Medicinal Ingredient(s):
Risankizumab
Control Number:
274993
Brand/Product Name:
Skyrizi
Therapeutic Area:
Immunosupressants
Type of Submission:
Supplement to a New Drug Submission
Decision Issued:
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 Supplement to a New Drug Submission (SNDS) was to seek market authorization for Skyrizi (risankizumab) for an additional 90 mg/mL presentation: a pre-filled syringe (PFS) containing 90 mg of risankizumab in 1 mL sterile solution for Crohn's disease (CD) maintenance treatment.
Skyrizi (risankizumab) has been authorized in Canada since April 2017 for the treatment of adults with moderate to severe plaque psoriasis, since March 2022 for the treatment of adults with active psoriatic arthritis and since October 2022 for the treatment of patients with moderate to severely active CD.
Why was the decision issued?
Crohn’s disease (CD) is a chronic inflammatory disease of the gastrointestinal tract characteristically associated with relapsing and remitting symptoms of abdominal pain, chronic diarrhea, weight loss, and fatigue. Symptoms present as acute periods of active symptoms (active disease or flare) among periods of quiescence (remission). CD is a progressive disease that can result in severe morbidity, including bowel damage, which may require surgery. Inflammation is typically segmental, asymmetrical, and transmural.
The purpose of this Supplement to a New Drug Submission (SNDS) was to seek market authorization for Skyrizi (risankizumab) for an additional 90 mg/mL presentation: a pre-filled syringe (PFS) containing 90 mg of risankizumab in 1 mL sterile solution for CD maintenance treatment. The new proposed presentation met the pre-specified criteria for bioequivalence when compared to the currently authorized presentation (i.e. on-body-delivery system).
The benefit-risk assessment for the use of Skyrizi in adult patients with moderate to severely active CD was previously established and considered favourable in the target patient population when the indication was originally authorized in 2022. Overall, based on the evaluation of this submission, and as labelled, the previously determined benefit-risk profile for the use of risankizumab as a treatment for adult patients with CD remains unchanged and favourable.
The chemistry and manufacturing information submitted for Skyrizi has demonstrated that the drug substance and drug product can be consistently manufactured to meet the approved specifications.
Following review and requested revisions, the final labelling and Product Monograph were considered to be acceptable.
For further details about Skyrizi, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.
Date of Decision:
2024-04-05
Manufacturer/Sponsor:
Drug Identification Number(s) Issued:
02546922
Prescription Status:
Schedule D drug
Date Filed:
2023-05-03
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| SKYRIZI | 02546922 | ABBVIE CORPORATION | RISANKIZUMAB 90 MG / 1 ML |