Regulatory Decision Summary for Ocrevus

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:

Selective Immunomodulator. Recombinant humanized monoclonal antibody that selectively targets CD20-expressing B-cells.

Type of submission:

New Drug Submission

Control number:

What was the purpose of this submission?


The purpose of this submission is to support the use of Ocrevus (ocrelizumab) in adult patients with primary progressive multiple sclerosis (PPMS).

The submission was approved under the Notice of Compliance with Conditions (NOC/c) pathway.


Why was the decision issued?


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.


Decision issued

Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.