FDA Approves Injectable Ocrevus Zunovo for MS

On Thursday, September 26, 2024, the U.S. Food and Drug Administration (FDA) granted approval for Ocrevus Zunovo, a combination of ocrelizumab and hyaluronidase-ocsq, as the first and only twice-yearly, 10-minute subcutaneous injection for individuals with relapsing and progressive multiple sclerosis (MS). This injection format is a notable advancement in MS treatment, providing patients with a more convenient administration method.

Administered by healthcare professionals, each dose requires patients to receive premedications at least 30 minutes prior to the injection. Following the injection, patients are monitored by their healthcare provider for at least 60 minutes for the first dose and for a minimum of 15 minutes for subsequent doses to ensure safety and manage any potential adverse reactions.

The FDA's approval was based on data from the phase 3 OCARINA II trial. This study demonstrated that the levels of Ocrevus in the blood were comparable whether administered subcutaneously or intravenously. Both methods showed similar safety and efficacy, with the subcutaneous form maintaining suppression of relapse activity and magnetic resonance imaging (MRI) lesions by 97 percent over a 48-week period. The trial also highlighted patient satisfaction, with over 92 percent of participants reporting they were satisfied or very satisfied with the subcutaneous injection method.

Adverse events were primarily injection reactions, affecting 49 percent of participants after the first injection. However, these reactions were generally mild to moderate in severity, and none were severe enough to necessitate withdrawal from the treatment.

Natalie Blake, the executive director of the MS Foundation, emphasized the importance of personalized treatment options for MS patients. She noted that since each person's experience with MS is unique, offering different methods of administration can better meet individual needs. Blake expressed satisfaction that the new delivery system provides another option for those requiring more flexibility in their treatment schedules.

The approval of Ocrevus Zunovo marks a significant step forward in MS treatment, offering patients a more convenient and less time-consuming administration alternative. This new method, developed by Genentech, aims to improve the quality of life for MS patients by reducing the burden of frequent treatments and providing effective disease management.

By introducing a twice-yearly subcutaneous injection, Ocrevus Zunovo simplifies the treatment regimen for MS patients, potentially increasing adherence and overall satisfaction with the treatment process. This advancement underscores the ongoing efforts to enhance therapeutic options and improve outcomes for those living with multiple sclerosis.