Why do we have a safety website, and what are the objectives?

Genentech is committed to transparent, timely communication of adverse events associated with the use of ocrelizumab in the treatment of relapsing forms of multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). This website is meant to serve as just one of the ways we will provide updated, verified safety information to healthcare professionals (HCPs).  We will also be providing safety information routinely through publications and presentations at major multiple sclerosis (MS) congresses.

What are some limitations of the content in this website?

This website is not a comprehensive source of safety information on ocrelizumab. Due to the nature of post-marketing adverse event reports, information may be duplicate and/or incomplete. Some of the investigations remain ongoing, and therefore the information is subject to change.  Additionally, the existence of an adverse event report does not establish causation. We evaluate these reports through our drug safety department, and attempt to verify the information to the extent possible. The Prescribing Information remains the primary source of information on the known and potential risks of ocrelizumab for RMS and PPMS.

What are post-marketing adverse event reports?

An adverse event is an untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. A post-marketing adverse event report is a report received by Genentech regarding an adverse event in a patient taking one of our marketed products.

Why do you only present post-marketing adverse event information for PML and fatalities?

Following the launch of the searchable FDA Adverse Event Reporting System (FAERS) public dashboard, Genentech received multiple inquiries regarding spontaneously reported fatalities and PML in patients who received ocrelizumab in the post-marketing setting. To address these inquiries and provide timely, accurate information, Genentech created this website. This website serves as just one of the ways in which we plan to communicate safety information. We welcome the FDA’s public dashboard, and share their vision for data transparency.

 

How does Genentech/Roche verify and report adverse events to the FDA?

Robust global systems are in place to continuously monitor the safety of a drug, from the time it is first evaluated in clinical studies through commercialization. All adverse event reports received by Genentech/Roche are reviewed, assessed, and due diligence is performed. The reports are then submitted to the FDA as per regulatory requirements.

Are there differences in the reported rates of adverse events between this site and those on the FDA Adverse Event Reporting System (FAERS) database?

Yes, this website includes post-marketing adverse event reports received by Genentech/Roche.  As part of our robust global pharmacovigilance process, these adverse event reports are reviewed, assessed, and due diligence is performed.

The FAERS database generally includes post-marketing cases reported by the Market Authorization Holder. However, FAERS may also include reports from clinical trials based on the specific requirements set in FDA regulations along with reports that are submitted voluntarily to the FDA by other resources. As the FDA acknowledges, unverified information, as well as incomplete or duplicate cases, can be reported in the FAERS dashboard.

How often is the website updated?

The current plan is for the website to be updated quarterly.

How do I get more information on the safety of ocrelizumab?

You may contact our Medical Communications department or a Medical Science Liaison (MSL) for any questions you may have regarding ocrelizumab. The Prescribing Information is the primary source of information on the known and potential risks of ocrelizumab for RMS or PPMS.