Regulatory Decision Summary for Kesimpta

The marketing authorization for Kesimpta was based on the results of two randomized, double-blind, double-dummy, active comparator-controlled clinical trials in patients with relapsing remitting multiple sclerosis (RRMS).

Treatment with Kesimpta demonstrated a 50.5% (Study G2301) and 58.5% (Study G2302) reduction of annualized relapse rate (ARR) as compared to teriflunomide.

Kesimpta significantly reduced the risk of disability progression by 34.4% at 3-month and by 32.5% at 6 month, compared to teriflunomide.

Kesimpta significantly reduce MS-related brain changes as measured by MRI (magnetic resonance imaging) compared to teriflunomide.

Kesimpta can cause systemic and local Injection Related Reactions (IRRs), increase risk of infections/opportunistic infections. Other safety concern include decrease in serum immunoglobulins. The safety information and mitigating measures are adequately described in the Kesimpta Product Monograph. A Risk Management Plan (RMP) was assessed and considered acceptable by Health Canada. The RMP provides measures for risk monitoring and mitigation in the post-market setting.

Overall, the benefit -risk profile of Kesimpta is positive for the treatment of adult patients with RRMS with active disease defined by clinical and imaging features.