Subcutaneous Ocrevus Zunovo Approved as Treatment for Primary Progressive and Relapsing MS

The Food and Drug Administration (FDA) has approved Ocrevus Zunovo (ocrelizumab & hyaluronidase-ocsq; Genentech, South San Francisco, CA) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). Ocrevus Zunovo is a subcutaneous formulation of Ocrevus which is administered by a health care provider (HCP) twice a year, with injections lasting approximately 10 minutes. The approval expands treatment options to centers that lack the ability to administer Ocrevus by intravenous infusion, potentially increasing the accessibility of treatment for people living with MS.

The approval was based on results of the phase 3 OCARINA II study (NCT05232825), which compared the safety, efficacy, and pharmacokinetics of subcutaneously vs intravenously administered Ocrevus for people with RMS and PPMS. A total of 236 participants with RMS and PPMS were included in the study. The primary study outcome was serum Ocrevus area under the concentration-time curve (AUCW) from day 1 to week 12, which showed no clinically significant differences between those who received subcutaneous injection vs intravenous infusion.

Other outcomes in the study in those assigned to subcutaneous Ocrevus were consistent with those taking intravenous Ocrevus:

• Through week 48, 97% of people who received subcutaneous Ocrevus showed no relapse activity and no MRI activity.
• 92% of trial participants were satisfied or very satisfied with subcutaneous administration of Ocrevus.
• The safety profile of subcutaneous Ocrevus was consistent with the well-established safety profile of intravenous Ocrevus, with no new safety signals.
• 49% of participants experienced an injection reaction after the first subcutaneous injection of Ocrevus.

After the first dose, a single treatment of Ocrevuz Zunovo could take as little as 1 hour to administer, with 30 minutes of premedication, 10 minutes of injection, and 15 minutes of postinjection monitoring. The first dose requires 60 minutes for postinjection monitoring.

“It’s crucial to acknowledge each experience with MS is as unique as the individual navigating it, so providing choices to address each person’s needs is essential,” said Natalie Blake, Executive Director of the MS Foundation. “We are pleased that with a new method of delivery, there is now an additional option for those who need flexibility in the route of administration or treatment time.”