Regulatory Decision Summary for Ilumya
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:
Medicinal ingredient(s):
Therapeutic area:
Type of submission:
Control number:
What was the purpose of this submission?
The purpose of this New Drug Submission was for the authorization of Ilumya (tildrakizumab injection) for the treatment of adults with moderate to severe plaque psoriasis. The submission had previously been given a Notice of Deficiency based on chemistry and manufacturing concerns that have now been addressed. The authorized indication is as follows:
Ilumya (tildrakizumab injection) is indicated for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Why was the decision issued?
- Authorization was based on two Phase III, international, double-blind, randomized controlled trials in adults with moderate to severe plaque psoriasis. Patients were treated with Ilumya (tildrakizumab injection) at a dose of 100 mg (n = 616) or 200 mg (n = 622) or placebo (n = 310) at the recommended dose regimen of Week 0, Week 4, and every 12 weeks for 52 or 64 weeks duration.
- The co-primary endpoints in the two Phase III trials were achievement of Psoriasis Area Severity Index (PASI) 75 and achievement of Physician Global Assessment (PGA) response (defined as PGA score of 0 or 1) at Week 12. There were significantly more patients treated with tildrakizumab 100 mg or 200 mg that achieved these endpoints compared to placebo-treated patients. Key secondary endpoints including PASI 90 and PASI 100 were also achieved by more tildrakizumab-treated than placebo-treated patients.
- The most common adverse event was nasopharyngitis. While nasopharyngitis was reported more frequently in the tildrakizumab 100 mg group (10.6%) than the placebo group (6.5%), the overall rate of infections and infestations was similar between the two groups. There were adverse events potentially indicative of drug hypersensitivity (e.g., urticarial, angioedema) but no cases of anaphylaxis.
The recommended dose of the drug is 100 mg administered at Week 0, Week 4, and every 12 weeks thereafter.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| ILUMYA | 02516098 | SUN PHARMACEUTICAL INDUSTRIES LIMITED | TILDRAKIZUMAB 100 MG / ML |