Regulatory Decision Summary for Ocrevus

Currently, Primary Progressive Multiple Sclerosis (PPMS) remains a severely disabling condition with no disease modifying therapies authorized by Health Canada. The efficacy of Ocrevus (ocrelizumab) was studied in one controlled clinical trial, and the results suggest potential benefit in at least some of the patients treated. However, the results are modest and not robust, and the clinical relevance of these findings is uncertain. It is for this reason that the Notice of Compliance with Conditions (NOC/c) pathway is used. The safety profile of Ocrevus is consistent with that of the previously authorized indication for Ocrevus for the treatment of patients with relapsing remitting multiple sclerosis (RRMS). As outlined in the approved Product Monograph, Ocrevus can cause serious Infusion Related Reactions (IRR), and increased risk of infections/ opportunistic infections and breast cancer. Other safety concerns include depression, cardiovascular events, hepatic/biliary/pancreatic events, neutropenia, and decreases in serum immunoglobulins.

No new safety concerns have been identified in the PPMS population.

Given the lack of therapeutic options available for Canadian patients with PPMS, the evidence provided in support of the efficacy of Ocrevus is considered promising with an "acceptable" safety profile. Therefore, the preliminary assessment of the Benefit/Risk can be considered favourable. Confirmation of efficacy in a well-designed clinical study is necessary to confirm the benefit-risk balance for Ocrevus and is a condition of authorization.