FDA approves injectable Ocrevus Zunovo for relapsing, progressive multiple sclerosis

The U.S. Food and Drug Administration has approved Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) as the first and only twice-a-year, 10-minute subcutaneous injection for people with relapsing and progressive multiple sclerosis (MS).

The injection is administered by a health care professional. Patients are given premedications at least 30 minutes prior to each dose and then monitored by their health care provider for at least 60 minutes after the injection. For subsequent doses, patients will be monitored for at least 15 minutes after the injection.

The approval was based on results from the phase 3 OCARINA II trial, which showed no clinically significant difference in the levels of Ocrevus in the blood when administered subcutaneously versus intravenously. The safety and efficacy profile was consistent with the intravenous formulation, with Ocrevus demonstrating suppression of relapse activity (97 percent) and magnetic resonance imaging lesions (97 percent) through 48 weeks. For patient-reported outcomes, more than 92 percent of participants reported being satisfied or very satisfied with the subcutaneous administration. The most common adverse events seen with Ocrevus were injection reactions, with 49 percent of participants experiencing a reaction after the first injection. All reactions were either mild or moderate, with none leading to treatment withdrawal.

“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,” Natalie Blake, executive director of the MS Foundation, said in a statement. “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.”

Approval of Ocrevus Zunovo was granted to Genentech.

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