The U.S. Food and Drug Administration approved Ocrevus Zunovo for the treatment of relapsing and primary progressive multiple sclerosis. One of several patient-reported outcomes showed more than 92 percent of trial participants reported being satisfied with treatment administration.

Ocrevus Zunovo is the only twice-a-year, healthcare professional-administered, approximately 10-minute subcutaneous injection approved for both relapsing and primary progressive forms of MS, giving people living with MS more treatment options. After the first dose, the time for treatment with Ocrevus Zunovo could be as short as 55 minutes. Patients will be required to take medications at least 30 minutes prior to each dose. Following the first dose, patients will be monitored by their healthcare professional for at least one hour. Patients will be monitored for at least 15 minutes postinjection for subsequent doses.

The FDA approval is based on data from the Phase III OCARINA II trial, which showed no clinically significant difference in the levels of Ocrevus in the blood when administered subcutaneously, and a safety and efficacy profile consistent to the IV formulation in people with RMS and PPMS. Out of the exploratory outcomes measured, Ocrevus Zunovo was consistent with IV, demonstrating suppression of relapse activity (97 percent) and MRI lesions (97 percent) through 48 weeks. Additionally, one of several patient-reported outcomes measured during the study showed more than 92 percent of trial participants reported being satisfied or very satisfied with the SC administration of Ocrevus Zunovo.

In the Phase III OCARINA II trial, the safety profile of Ocrevus Zunovo was consistent with the well-established safety profile of Ocrevus IV. The most common adverse events with Ocrevus Zunovo were injection reactions. Injection reactions were more frequently reported with the first injection, with 49 percent of trial participants experiencing an injection reaction after the first injection. All injection reactions were either mild or moderate, and none led to treatment withdrawal.