| Drug Name |
OCREVUS ZUNOVO™ (ocrelizumab & hyaluronidase-ocsq) |
| Active Ingredient |
ocrelizumab & hyaluronidase |
| Date of Approval |
September 13, 2024 |
| Manufacturer |
Genentech, Inc. |
| Approval Pathways and Indications |
Approval Pathway: NDA
Indication: OCREVUS ZUNOVO™ is indicated for the treatment of relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, as well as primary progressive multiple sclerosis (PPMS) in adults. |
| Therapeutic Class |
CD20-directed cytolytic antibody and endoglycosidase combination |
| Formulation |
Injection: 920 mg ocrelizumab and 23,000 units hyaluronidase per 23 mL (40 mg and 1,000 units per mL) solution in a single-dose vial |
| MoA |
Ocrelizumab's therapeutic effects in multiple sclerosis (MS) are thought to arise from its binding to CD20 on pre-B and mature B lymphocytes. This binding leads to the destruction of these cells through antibody-dependent cellular cytolysis and complement-mediated lysis. Additionally, hyaluronidase, present in OCREVUS ZUNOVO™, temporarily increases the permeability of subcutaneous tissue by breaking down hyaluronan, a polysaccharide found in the extracellular matrix. This effect is local and reversible, with tissue permeability returning to normal within 24 to 48 hours. |
| Dosing and Administration |
The recommended dosage of OCREVUS ZUNOVO™ is 920 mg/23,000 units administered as a single 23 mL subcutaneous (SQ) injection in the abdomen over approximately 10 minutes every 6 months.
OCREVUS ZUNOVO™ is indicated for SQ use in the abdomen only.
Hepatitis B virus and quantitative serum immunoglobulin screening are required before the first dose. Active hepatitis B virus infection is a contraindication to OCREVUS ZUNOVO™ administration.
Patients should pre-medicate orally with dexamethasone (or an equivalent corticosteroid) and an antihistamine (e.g., desloratadine) at least 30 minutes prior to each injection.
HCPs should monitor patients closely during all injections, for at least one hour after the initial injection, and for at least 15 minutes after subsequent injections |
| Administered by self or by HCP |
Administered by HCP |
| Place in Therapy |
Multiple sclerosis is a chronic disease that affects more than 2.9 million people worldwide. The approval of OCREVUS ZUNOVO™ makes ocrelizumab and hyaluronidase the first and only twice-yearly, HCP-administered SQ injection approved for RMS and PPMS, expanding treatment options for patients.
Each SQ injection takes approximately 10 minutes, compared to 2.5 hours with IV administration for the initial doses and at least two hours for subsequent doses.
The safety, efficacy, and side effect profile of OCREVUS ZUNOVO™ mirrors that of Ocrevus, with only administration being the notable difference. Significant warnings for OCREVUS ZUNOVO™ include injection-site reactions, risk of infection, Progressive Multifocal Leukoencephalopathy (PML), reduction in immunoglobulins, increased risk of malignancies, and immune-mediated colitis. |
| Expected Market Launch Date |
Data Unavailable |
| New Molecular Entity (NME) or Existing Formulation |
Existing Formulation |
| Expected Cost |
Genentech has announced that Ocrevus Zunovo will have an initial annual list price at parity with Ocrevus IV; Ocrevus IV currently costs approximately $78,858 annually as of September 10, 2024. |
| Product Discontinuation |
N/A |
| Clinical Trials |
The FDA approval is based on pivotal data from the Phase III OCARINA II trial, which showed no clinically significant difference in the levels of Ocrelizumab 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%) and MRI lesions (97%) through 48 weeks. Additionally, one of several patient-reported outcomes measured during the study showed more than 92% of trial participants reported being satisfied or very satisfied with the SQ 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, with the exception of injection reactions. The most common adverse events with OCREVUS ZUNOVO™ were injection reactions. Injection reactions were more frequently reported with the first injection, with 49% 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. |
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FDA Approves Ocrevus Zunovo (Ocrelizumab and Hyaluronidase-oysk) for Twice-Yearly Subcutaneous Use in Relapsing MS. Drugs.com. https://www.drugs.com/newdrugs/fda-approves-ocrevus-zunovo-ocrelizumab-hyaluronidase-ocsq-twice-year-subcutaneous-relapsing-6367.html. Published September 13, 2024. Accessed September 19, 2024.
Subcutaneous Ocrelizumab and Hyaluronidase Approved for RMS, PPMS. AJMC. https://www.ajmc.com/view/subcutaneous-ocrelizumab-and-hyaluronidase-approved-for-rms-ppms. Published September 13, 2024. Accessed September 19, 2024.
Ocrevus (Ocrelizumab) [prescribing information]. South San Francisco, CA: Genentech, Inc.; 2024. https://www.gene.com/download/pdf/ocrevus_prescribing.pdf. Accessed September 19, 2024.
FDA Approves Ocrevus Zunovo as the First Subcutaneous Formulation. Genentech. https://www.gene.com/media/press-releases/15036/2024-09-13/
fda-approves-ocrevus-zunovo-as-the-first. Published September 13, 2024. Accessed September 19, 2024.
Ocrevus Cost and Coverage Information. Genentech. https://www.ocrevus.com/patient/cost.html?c=ocr-18deca9ed8a&&user_id=N848755.1282461522170660298&gclid
=Cj0KCQjw9Km3BhDjARIsAGUb4nzJkrSVqPg6tEz-modGWLISQ0tDyccWu8EmtPw3yXeb3KYv2SdnAZwaAkTXEALw_
wcB&gclsrc=aw.ds. Accessed September 19, 2024.
Ocrevus Zunovo (Ocrelizumab and Hyaluronidase) [prescribing information]. South San Francisco, CA: Genentech, Inc.; 2024. https://www.gene.com/download/pdf/ocrevus_zunovo_prescribing.pdf. Accessed September 19, 2024. |