Genentech, part of the Roche Group, has announced that the U.S. Food and Drug Administration (FDA) has approved Ocrevus Zunovo™ (ocrelizumab & hyaluronidase-ocsq) for treating both relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). Ocrevus Zunovo is the first and only subcutaneous (SC) injection of its kind that healthcare professionals can administer twice a year, with each injection taking about 10 minutes. This new option provides people with MS more flexibility in their treatment.
Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of Global Product Development, highlighted that Ocrevus Zunovo builds on a decade of proven safety and efficacy for Ocrevus in treating multiple sclerosis. “Today’s approval introduces greater flexibility for healthcare providers and patients by offering a new option that caters to individual treatment needs,” Garraway said.
Natalie Blake, Executive Director of the MS Foundation, emphasized the importance of expanding treatment options. “With advancements in medicine, people are living longer and with fewer disabilities. However, not everyone has access to these treatments. Each person’s experience with MS is unique, so providing choices is essential. We’re pleased to see a new delivery method that offers more flexibility for those needing it.”
After the initial dose, treatment with Ocrevus Zunovo can be completed in as little as 55 minutes. Patients must take premedications 30 minutes before each dose, and will be monitored by their healthcare provider for at least 60 minutes after the first dose and for 15 minutes after subsequent doses.
The FDA’s approval is supported by data from the Phase III OCARINA II trial, which demonstrated no significant difference in blood levels of Ocrevus when administered subcutaneously compared to the intravenous (IV) form. The trial showed that Ocrevus Zunovo effectively suppressed relapse activity and MRI lesions, with 97% suppression through 48 weeks. Additionally, over 92% of trial participants were satisfied with the subcutaneous administration.
The safety profile of Ocrevus Zunovo mirrors that of the IV formulation, with the main adverse events being injection reactions. These reactions were generally mild to moderate, occurring in 49% of participants after the first injection, and none led to treatment discontinuation.
Genentech remains committed to advancing clinical research and enhancing patient care for multiple sclerosis. With over 30 ongoing trials, the company aims to deepen its understanding of the disease and improve treatment experiences. Ocrevus Zunovo is part of Genentech’s broader efforts to offer diverse treatment options and support patients throughout their treatment journey.
