FDA Approves Ocrevus Zunovo: A Breakthrough Subcutaneous Injection for Multiple Sclerosis

FDA Approval:
The U.S. Food and Drug Administration (FDA) has approved Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS) in adults.

Subcutaneous Injection:
Ocrevus Zunovo is the first and only twice-a-year, approximately 10-minute subcutaneous injection approved for both RMS and PPMS, offering greater flexibility for healthcare providers and patients.

ENHANZE Technology:
The drug combines Ocrevus with Halozyme Therapeutics' ENHANZE drug delivery technology, which facilitates rapid subcutaneous delivery and reduces treatment burden.

Clinical Data:
The approval is based on pivotal data from the Phase III OCARINA II trial, which demonstrated non-inferior levels of Ocrevus in the blood when administered subcutaneously, and a safety and efficacy profile comparable to the intravenous (IV) formulation.

Patient Satisfaction:
Over 92% of trial participants reported being satisfied or very satisfied with the subcutaneous administration of Ocrevus Zunovo.

Treatment Flexibility:
Ocrevus Zunovo has the potential to expand treatment options to centers without IV infrastructure or with IV constraints, such as doctor’s offices.

Safety Profile:
The safety profile of Ocrevus Zunovo was consistent with the well-established safety profile of Ocrevus IV, with the exception of injection reactions, which were mild or moderate and did not lead to treatment withdrawal.