Regulatory Decision Summary for Tremfya

Tremfya was superior to placebo with regard to an Investigator Global Assessment (IGA) response of 0 or 1 at Week 16 (85% vs. 7%, and 84% vs. 8% in pivotal trials VOYAGE 1 and VOYAGE 2, respectively) and a Psoriasis Area and Severity Index (PASI) 90 response at Week 16 (73% vs. 3%, and 70% vs. 2%, respectively). Tremfya was also statistically superior to adalimumab at Weeks 16 and 24 for both endpoints.

The most common adverse effects of Tremfya are non-serious upper respiratory infections, headache, injection site reactions, arthralgia, elevated liver enzymes, diarrhea, gastroenteritis, tinea infections, and herpes simplex infections.

Tremfya provides an alternative to treatment with phototherapy, methothrexate, apremilast, anti-TNFα agents, ustekinumab, secukinumab and ixekizumab.

MHPD reviewed the Risk Management Plan (RMP). The use of Tremfya in patients ≥65 years of age was flagged for attention because of their limited numbers in the clinical program. Along with routine pharmacovigilance activities, the Sponsor has proposed two long-term extension Phase 3 studies and an observational cohort study to further characterize safety beyond 1 year of exposure.

By virtue of its established efficacy and safety, Tremfya has demonstrated a favourable benefit/risk ratio.

For more information on Health Canadas decision, please view the Summary Basis of Decision.