Ocrevus Zunovo FDA Approval History

Last updated by Judith Stewart, BPharm on Oct 29, 2024.

FDA Approved: Yes (First approved September 13, 2024)
Brand name: Ocrevus Zunovo
Generic name: ocrelizumab & hyaluronidase-ocsq
Dosage form: Injection
Company: Genentech, Inc.
Treatment for: Multiple Sclerosis

Ocrevus Zunovo (ocrelizumab & hyaluronidase-ocsq) is a CD20-directed cytolytic antibody and hyaluronidase combination used for the treatment of people with relapsing and progressive multiple sclerosis (MS).

• Ocrevus Zunovo is indicated for:
  - relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults.
  - primary progressive multiple sclerosis (PPMS) in adults.
• Ocrevus (ocrelizumab) was first approved in 2017 as an injection formulation for intravenous (IV) infusion. Ocrevus Zunovo is a new injection formulation containing hyaluronidase-ocsq that is administered subcutaneously over a period of approximately 10 minutes, compared with 2 to 3.5 hours for the standard IV infusion of Ocrevus. Both Ocrevus and Ocrevus Zunovo are administered every six months.
• Ocrevus is a monoclonal antibody designed to target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin and axonal damage in people with MS. Ocrevus Zunovo combines Ocrevus with the Enhanze^® drug delivery technology which is based on a proprietary recombinant human hyaluronidase PH20 (rHuPH20), an enzyme that locally and temporarily degrades hyaluronan in the subcutaneous space. This increases the permeability of the tissue under the skin, allowing space for Ocrevus to enter, and enabling it to be rapidly dispersed and absorbed into the bloodstream.
• FDA approval for Ocrevus Zunovo was base on pivotal 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 (with the exception of injection reactions). 
• Warnings and precautions associated with Ocrevus Zunovo include injection reactions, serious infections, progressive multifocal leukoencephalopathy (PML), reduction in immunoglobulin levels, an increased risk of malignancy, and immune-mediated colitis.
• Common adverse reactions:
  - in patients with RMS receiving intravenous ocrelizumab include upper respiratory tract infections and infusion reactions.
  - in patients with PPMS receiving intravenous ocrelizumab include upper respiratory tract infections, infusion reactions, skin infections, and lower respiratory tract infections.
  Common adverse reactions:
  - in patients with RMS and PPMS receiving Ocrevus Zunovo include injection reactions.

Development timeline for Ocrevus Zunovo

Further information

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