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# Genentech’s Ocrevus Zunovo Approved for MS
- URL: https://www.fdaweb.com/genentechs-ocrevus-zunovo-approved-for-ms/
- Published: 2024-09-13T12:00:00.000Z
- Updated: 2026-09-14T14:41:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157775

FDA has approved Genentech’s Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) twice-a-year subcutaneous injection for treating relapsing multiple sclerosis and primary progressive multiple sclerosis. “Ocrevus Zunovo gives patients and providers another option for receiving Ocrevus, building on a decade of robust safety and efficacy data for Ocrevus in multiple sclerosis,” the company says.

Approval is based on data from the Phase 3 OCARINA II trial, which showed no clinically significant difference in the levels of Ocrevus in the blood when administered subcutaneously. It also showed a safety and efficacy profile consistent to the currently approved intravenous (IV) formulation. “Out of the exploratory outcomes measured, Ocrevus Zunovo was consistent with IV, demonstrating suppression of relapse activity (97%) and MRI lesions (97%) through 48 weeks,” according to the company.

Ocrevus Zunovo is described as combining Ocrevus with Halozyme Therapeutics’ Enhanze drug delivery technology. The monoclonal antibody is designed to target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage, Genentech says. “Based on preclinical studies, Ocrevus binds to CD20 cell surface proteins expressed on certain B cells, but not on stem cells or plasma cells, suggesting that important functions of the immune system may be preserved,” it adds.